Supplier News 2018

What Will 2019 Bring for Medtech?
new-years-day-3683748_640.jpg Type Image Caption Healthcare is definitely changing, evident from several developments in 2018. While payers and providers have been working for some...

Edwards Heats up TAVR Market with New Approval
Edward Lifesciences’s long-awaited Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) System has received a nod from FDA. The Irvine, CA-based company had received CE mark for the valve in November.The Sapien 3 Ultra valve features a heighten...

Obalon Scores Funding on the Heels of Obesity Market Shift
Two new funding deals could give Obalon the added firepower needed for it to more effectively compete in the obesity treatment market. The San Diego-based company said it has garnered $30 million from a stock purchase agreement with Lincoln Park Fund a...

AI Aids in Detecting Multiple Conditions with One Chest CT
A new technology that works with existing computed tomography (CT) is aimed at reducing radiologist workflow and ultimately saving patient lives by enabling doctors to provide earlier diagnoses.“The InferRead CT Chest scan is a AI-based algorithm that ...

Latest Boston Sci Deal Shakes up Mitral Repair Market
Boston Scientific is slipping in one more deal (maybe?) before 2018 ends, and it could have significant implications. This time out, the Marlborough, MA-based company will gain a stronger foothold in the transcatheter mitral repair and replacement mark...

CDx Diagnostics Continues to Shine with Strong Data
A newly published study of CDx Diagnostics’s WATS3D, which employs artificial intelligence (AI), continues to show the effectiveness of the test for the detection Barrett’s esophagus. The nearly 13,000-patient study was published in Diseases of the Eso...

Beta Bionics Wins Readers' Choice for Medtech Company of the Year
The people have spoken. Beta Bionics has been named medtech company of the year. Nearly 44% of MD+DI readers participating in a special poll voted for the Boston, MA-based company, which is developing an artificial intelligence-powered bionic pancreas,...

Essure Discontinuation Doesn't Mean the End to FDA Scrutiny
FDA wants the public to know it is taking steps to make sure the long-term safety profile of a controversial birth control device continues to be studied even after U.S. sales of the device are discontinued at the end of the year. While this seems like...

Paragonix Gets FDA Nod for Pediatric Heart Transport Device
Paragonix Technologies is hoping to offer a more effective way of transporting transplant hearts to pediatric patients. The Braintree, MA-based company said it has received clearance from FDA for a design enhancement allowing the Paragonix SherpaPak Ca...

Supplier Stories for the Week of December 16

Top Medtech News of 2018

3M Gets in Last Minute M&A Before Year’s End
It seems like medtech companies are scrambling to get that last bit of M&A done before the year ends. 3M is popping up on the deal radar, with its plan to acquire M* Modal’s technology business for a total enterprise value of $1 billion. The deal is ex...

Alcon's Acquisition Is a Real Tear-Jerker
Alcon's anticipated split from Novartis has yet to be completed but the eye care business already is looking for ways to build out its portfolio for when it becomes a standalone company. Alcon reported Wednesday that it has acquired Tear Film Innovatio...

Medtech Losers of 2018

Predict and Prevent: The Emergence of Real-Time Sensor-Based Care
Technology industry veteran Eran Ofir knows there is a lot of luck involved in successfully bringing a new device, especially one designed to create a new treatment vector, to market.Ofir is the CEO and co-founder of New York-based Somatix, which uses ...

Apollo Says Goodbye to Lap-Band as It Reshapes Portfolio
Apollo Endosurgery is selling its surgical product line, which includes the Lap-Band adjustable gastric banding system to its rival Reshape Medical. In addition, ReShape will deal its intra-gastric balloon line to Austin, TX-based Apollo. The transacti...

ImpediMed Launches Lymphedema Assessment System
As everyone knows, cancer treatment can be very tough on patients. One of the most common complications is something known as bilateral lymphoedema, a condition that causes significant swelling in the arms or legs. This condition is typically caused by...

Medtech Winners of 2018
cup-1614530__480.png Type Image Caption These companies, people, technologies, and concepts had a great year in 2018. Gating level anonymous user DataTa...

Considering Old and New 510(k) Predicates
The 510(k) route to market for Class II devices involves the comparison of the candidate device to a legally marketable (already cleared) device. Note that the predicate device need not actually be on the market. There are several guidances on doing th...

FDA Approves Smart Programmer for Medtronic Neuromodulation System
FDA approved a new smart programmer for Medtronic's InterStim system, which provides sacral neuromodulation therapy for the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention.The new programmer...

How Boston Scientific Reinvented Itself in 2018
When MD+DI editors were voting to see which medtech firm would be named 2018 Company of the Year, Boston Scientific immediately stood out. The Marlborough, MA-based company has had an incredible year. From deals, to a more open line of communication, t...

Sensor Platform for Flow Measurement in Respiratory Devices
Sensirion, the innovation driver and leading manufacturer of flow and environmental sensors, will be presenting its sensor platform for flow measurement in respiratory devices at the medical technology trade fair COMPAMED 2018

Abiomed’s New Collaboration Could Cause Shockwaves in Industry
Abiomed and Shockwave Medical just got a little bit closer. Recently the two companies announced that Danvers, MA-based Abiomed and one of the MDDI 2017 company finalists would be investing about $15 million in Shockwave. In addition, the two firms wo...

Fertility Tracker Guarantees Pregnancy Within One Year
Until recently, detecting the time during a woman’s cycle when she is most likely to conceive has been imprecise. Methods included measuring basal temperature spikes, which only detect ovulation after the fact, or urine tests that indicate a surge in l...

How a Tiny Device Is Making a Big Difference for Pediatric Transplant Patients
Imagine being a pediatric kidney transplant patient and having to miss school or extracurricular activities because of clinic appointments and routine blood tests. Now imagine being offered a take-home kit that has everything you and your caregivers ne...

Medtech Hasn’t Abandoned the Thought of M&A yet in 2018
The year might be rapidly ending, but there’s still enough time for medtech companies to do some fairly large deals before 2019. Sonic Healthcare is taking a plunge into M&A before year’s end and picking up Aurora Diagnostics for $540 million.The deal ...

Operating Rooms Get a Dose of Augmented Reality
Operating rooms are set to get a dose of augmented reality because of a new clearance from FDA. The agency recently signed off on an augmented surgical navigation system from Mariner Endosurgery.The Ontario-based company’s LaparoGuard is an augmented s...

Apple's Medical Hires: Big Deal or Much Ado About Nothing?
Apple has been careful to keep its future healthcare plans under wraps, but whatever it is, expect that it will be big.“Apple has a huge opportunity in health … and I don’t want to talk about the future because I don’t want to give away what we’re doin...

Applying effective heat seals – by OK Sealer
OK Sealers latest addition to its line of pouch sealers

Colorectal Cancer Screening Pill to Be in US Pilot Study
Check-Cap is getting one step closer to having its capsule-based screening method for colorectal cancer on the U.S. market. The Isfiya, Israel-based company has received FDA conditional approval for an IDE to initiate a pilot study of the C-Scan capsul...

Study Links Air Pollution with Rescue Inhaler Use
A recent study concludes that there is a strong and significant association between daily exposure to fine particulate matter (PM2.5), which refers to tiny particles or droplets in the air that are two and a half microns or less in width, and the frequ...

Supplier Stories for the Week of December 9

Can One App Help Stem the Tide of Opioid Abuse?
Digital health solutions could be the most viable means of curbing the opioid abuse epidemic. FDA contributed to the support of this belief earlier this week, when it gave a nod to Pear Therapeutics’ mobile medical app. The solution, called reSET-O, is...

Could Devices Help Pharma Improve Outcomes?
Many of today’s pharmaceuticals are delivered by a specialized device. To explore all the considerations that go into bringing such complex products to market as well as the potential benefits for patients, MD+DI checked in with Chrissy Bell, Global Bu...

How One Engineer's Blood Disorder Enabled the Development of an Anemia Detection App
Every month from the time he was six months old, Rob Mannino has had to go into a clinic to receive a blood transfusion. Mannino has an inherited blood disorder known as beta-thalassemia, which is caused by a mutation in the beta-globin gene.“My doctor...

New Field Test Discerns Between Ebola and Lookalike Fevers
At the close of the 2014-2016 West Africa Ebola crisis, the Paul G. Allen Foundation identified diagnostic gaps as one of the major deficiencies that had contributed to the outbreak’s spread.“The standard diagnostic tests that exist are very good, but ...

Picosun launches new PicoMEDICAL™ solutions specially targeted for healthcare industries
ESPOO, Finland, 9th October 2018 – Picosun Group, a leading, global provider of ALD (Atomic Layer Deposition) thin film coating technology, strengthens its position in the healthcare market with new PicoMEDICAL™ solutions specially developed for the ne...

Can Olympus Finally Put Its Scope Problems in the Past?
Olympus has been plagued with lawsuits and criminal investigations stemming from problems with its duodenoscopes for more than three years, but a plea agreement with the U.S. Department of Justice could help Olympus learn from its mistakes and move on....

Medtech Company of the Year 2018 Finalists

Reprocessed Duodenoscopes Are Still Too Dirty
Preliminary findings from sampling studies of duodenoscopes currently in clinical use indicate higher-than-expected contamination rates after reprocessing, FDA reported in a safety notice this week. The news coincided with Olympus agreeing to pay $85 m...

Using AI to Get a Better Understanding of Cancer Cells
Researchers from Osaka University have developed an artificial intelligence-based system that can differentiate cancer cells.The researchers findings were presented in an article titled “A convolution neural network uses microscopic images to different...

WhiteSwell Develops a Different Way to Treat Heart Failure
A small medtech company is looking at tackling a huge problem in one of the toughest markets to navigate in healthcare. Galway, Ireland-based WhiteSwell has set its sights on developing a minimally invasive catheter approach that can drain the excess f...

Fresenius Expands Presence in China With Investments and Acquisitions
Fresenius Medical Care is letting it be known that it wants to have a stronger presence in China, one of the fast-growing emerging markets. Last week the Bad Homberg, Germany-based company announced a ton of acquisitions and investments in dialysis cen...

Large Companies Eye Collaboration as Entry into AI
Edwards Lifesciences is delving deeper into the realm of artificial intelligence through a partnership with San Francisco-based Bay Labs. The goal of the collaboration, which has multiple initiatives is to improve the detection of heart disease.Some of...

The Cloud of Uncertainty Thickens Over MiMedx As Auditor Quits
The hits just keep coming for MiMedx Group this year. Ernst & Young (EY), the firm hired to audit the company's financial statements for the past two years, has resigned after advising the company that the internal controls necessary for MiMedx to deve...

Are Medtech Companies Still Interested in M&A?
Medtech companies are not that “interested” in M&A anymore, according to a survey taken during a recent MD+DI webinar discussing Medtech Trends and Adaptation. Arda Ural, Phd, a partner, transaction advisory services practice for Ernst and Young (EY) w...

CardioFocus Finishes up Enrollment for HeartLight X3 Trial
CardioFocus is looking to bring the next generation of its endoscopic ablation system to the market and that could happen sometime next year. The Marlborough, MA-based company and finalist in MD+DI’s Manufacturer of the Year Award in 2012, took bold st...

Globus Scales Efforts Abroad with European Launch of ExcelsiusGPS
Globus Medical has officially entered Europe with its robotic guidance and navigation system, the ExcelsiusGPS.The Audobon, PA-based company said the first European ExcelsiusGPS procedure was performed in October at the Metropolitan Hospital in Neo Fal...

How a Coaxial Alternative Could Make Way for Smaller Catheters
The Tokyo, Japan-based supplier launched its Multi-Channel Transmission (MCT) at MD&M Minneapolis in late October. The new solution could challenge existing twisted pair coaxial and flexible printed circuit technology. Junkosha said MCT will enable new...

Investigators on the Path to Alzheimer’s Detection Test
Brigham and Women’s Hospital investigators are working on a test that could either diagnose or predict Alzheimer’s disease before symptoms appear. The investigators approach is in the December issue of Alzheimer’s & Dementia.Tau proteins have long been...

Medical manufacturer’s products likely made for someone you love
Innovize featured in the Vadnais Heights Press article

Supplier Stories for the Week of December 2

Could AI Become the New Quality Control Manager in Medical Device Manufacturing?
Quality is of utmost concern to manufacturers everywhere, but perhaps nowhere does it hold greater importance than in the plant where medical devices are being made and defects can have life or death consequences. Think for a second about the implicat...

GRAIL’s SUMMIT Will Help Define its Liquid Biopsy Path
A long-awaited and massive study with major implications for the liquid biopsy market is slated to start next year. Earlier this week, GRAIL revealed that it would initiate its 50,000-patient SUMMIT study in early 2019.Ages of the patients will be men ...

Past Covidien, ev3 Activities are Costing Medtronic a Hefty Sum
Sometimes acquiring other companies means taking the bad with the good. In Medtronic's case, that means settling multiple Department of Justice claims against ev3, a business Medtronic owns by way of its Covidien acquisition.Covidien bought ev3 in 2010...

Tiny Wearable Device Warns of Exposure to UV Light
Northwestern Medicine and Northwestern’s McCormick School of Engineering scientists have developed what is being called the world’s smallest wearable, battery-free device to measure light. The technology enables scientists to measure exposure to light ...

Are Smaller Hip Implants in Older Patients More Cost Effective?
A study by researchers at the University of Bristol Medical School has shown that small-head cemented metal-on-plastic hip replacements less than 36 mm in diameter are the most cost-effective in patients older than 65.The research was led by the Hip Im...

FDA Wants to Change the De Novo Pathway
Last week, FDA revealed plans to modernize the 510(k) clearance pathway, which was adopted in 1976 and now accounts for the majority of medical devices the agency reviews. This week, the agency has turned its attention to the de novo pathway for medica...

Is 2019 Going to Be a Standout Year for TAVR?
JenaValve has won a nod from FDA for expanded IDE enrollment of its transcatheter aortic valve replacement (TAVR) system. The agency’s nod is aimed at feasibility studies for the JenaValve Pericardial TAVR System with the Everdur transcatheter heart va...

Meet the Post-Op Bra That's Long Overdue
Efrat Roman was diagnosed with breast cancer a little more than a decade ago and underwent a total of five different surgeries due to complications. As if going through multiple breast operations weren't challenging enough, Roman was surprised to find ...

Pushing 3D Printing Forward
Researchers and students have demonstrated that inks can be used instead of thermoplastic filaments to 3D print functional biomedical devices. Michael McAlpine, Benjamin Mayhugh Associate Professor of Mechanical Engineering at the University of Minneso...

What Can Medtech Expect with the New Congress?
Given the drop in warning letters over the past few years and the expansion of the Medical Device Single Audit Program, it appears that FDA has been implementing a policy of “voluntary” compliance. However, FDA policy is basically controlled by Congres...

Diabeloop Is 2nd to Win CE Mark for Artificial Pancreas System
Medtronic has a new contender for its MiniMed 670g insulin pump, dubbed the artificial pancreas. The Dublin-based company could see a healthy competitor in Diabeloop, a small firm that recently won CE-mark for DBLG1, a hybrid closed-loop diabetes manag...

Concept Device Designed to Tame Menopausal Hot Flashes
According to the Study of Women’s Health Across the Nation (SWAN), up to 80% of women experience vasomotor menopausal symptoms, including hot flashes and night sweats, when transitioning into and through menopause. Most of the women studied rated their...

New Corindus Technology Successfully Used in Robotic-Assisted Coronary Intervention
The future of robotic-assisted surgery emerges ever closer with the news of Corindus Vascular Robotics's new CorPath GRX System being successfully used to enable robotic-assisted percutaneous coronary interventions (PCI) at the recent Transcatheter Car...

The Truth, The Whole Truth, and Nothing But The Truth
In his latest post at www.uson.com, Joe pustka calls out inaccurate instrument specifications and gives advice on how to tell if you are being misled.

Auris Scores Big with $200M Raise for Robotics Platform
The robotics market is surging. Auris Health recent raise of $200 million to commercialize the Monarch Platform is a perfect example. The Redwood City, CA-based company has raised more than $700 million to develop and commercialize the Monarch platform...

Expediting 3D Analysis of Normal and Diseased Tissues
The current gold standard for tissue analysis, formalin fixation paraffin embedding (FFPE) followed by 2D thin sectioning, has been around for more than a century. And like any 100-year-old technology, it has key limitations.. So, ClearLight Biotechnol...

New Virtual Surgical Simulator Debuts in Germany
Researchers presented the latest innovation in surgical training at this year’s MEDICA 2018 conference in Düsseldorf, Germany — the HandsOn.surgery trainer. The new prototype was designed to help surgeons prepare for individual patient surgeries by ena...

REACH FAQs for Medical Device Professionals
REACH stands for Registration, Evaluation, and Authorisation of Chemicals. It is European Union Regulation No 1907/2006. It has many objectives, the most pertinent of which to medical devices is to improve the protection of human health and the environ...

Surveying the Digital Health Device Landscape in Clinical Trials
From text messages to mobile apps, digital health devices are becoming increasingly important in clinical trials for their ability to streamline trials, lower site burden, and improve the patient experience. However, manufacturers must consider the saf...

First Device Cleared for the Prevention of Cluster Headache
Cluster headache is considered one of the most painful conditions known to mankind. While there are drugs and devices designed to treat these sudden and excruciating headaches, there are currently no FDA-approved pharmacologic treatments for the preven...

J&J Subsidiary Launches IDE Study for AF
A new U.S. study aims to evaluate a radiofrequency (RF) balloon ablation catheter for the treatment of symptomatic drug refractory recurrent paroxysmal (intermittent) atrial fibrillation.Biosense Webster, a subsidiary of Johnson & Johnson, said the inv...

Supplier Stories for the Week of November 25

7 Key Moments for the Digital Health Space in 2018

Does It Make Sense to Retire Old Predicate Devices for FDA Clearance?
Earlier this week, FDA revealed plans to modernize the 510(k) clearance pathway, which was adopted in 1976 and now accounts for the majority of medical devices the agency reviews. Currently, in order to qualify for a 510(k) clearance, new devices have ...

How a New Blood Volume Analyzer Could Save Lives From Acute Heart Failure
An innovative new medical instrumentation and biotechnology company known as Daxor just published some exciting new data for their flagship technology, the BVA-100 blood volume analyzer. The new technology is designed to quantify circulating total bloo...

How Can Nanotechnologies Aid Implantable Drug-Delivery Systems?
Implantable technologies have come a long way over the years, and advancements in micro and nanotechnologies have helped device developers continue to push the envelope even further. Within the realm of drug delivery, advances in nanotechnologies have ...

Qosina Announces E-commerce Website Update
Qosina announces the launch of its newly redesigned e-commerce website

Voice-Activated Kits Aid Helpers in a Bleeding Emergency
Step-by-step audio, pictorial, and written instructions guide bystanders in emergency situations to confidently treat bleeding injuries.“Despite the advances in trauma care and lessons learned from the military, some 80,000 lives are lost in the United...

5 Key Questions to Determine if That Contract Manufacturer is a Good Fit for You
We welcome you to ask Innovize these 5 questions.

Another EpiPen Is Now on the Market
Teva Pharmaceuticals has finally launched its generic version of Mylan’s EpiPen.  The Petah, Tikvah, Israel-based company’s emergency allergy shot will be priced at $300 – the same as Mylan’s generic. Teva received approval for its version of EpiPen in...

Google Doodle Honors First Woman Admitted to Harvard Medical School
By now most Internet users are familiar with Google Doodles, a program in which Google illustrators make changes to the company's logo to celebrate holidays, anniversaries, and the lives of famous artists, pioneers, and scientists. Tuesday's Google Doo...

Oscar Recalls Pacing Leads Due to a Connection Cap Malfunction
A Florida-based medical device company is recalling certain lots of its temporary bipolar pacing leads that are used for temporary pacing and sensing of the heart in conjunction with a compatible external pulse generator.Palm Harbor, FL-based Oscor Inc...

Zimmer Biomet Recalls 1,300 Bone Growth and Spinal Fusion Stimulators
A recall that Zimmer Biomet initiated in February has just been identified by FDA as a Class I recall, marking it the most serious type of medical device recall. The company is recalling 1,360 implantable bone growth and spinal fusion stimulators that ...

FDA Eyes Changes to 510(k) Program
FDA wants to modernize the 510(k) clearance pathway, which was adopted in 1976 and now accounts for the majority of medical devices the agency reviews.The agency said it is pursuing changes to the program in an effort to help keep pace with the increas...

FDA Gets out in Front of Injection Pen Errors
In recent years, our human factors researchers have seen a few persistent use errors in usability studies that involve injection pens. Many home users—patients and caregivers—encounter confusion when interacting with the shields covering the disposable...

Investigative Report Casts a Troubling Light on the Medical Device Industry
The consumer media has not been kind to the medical device industry this year. A consortium of journalists released an investigative report on the industry over the weekend that blames poorly regulated medical devices for millions of patient injuries a...

Medtronic Eyes Familiar Face in New Acquisition
Medtronic is acquiring, Nutrino, a company that uses artificial intelligence for nutrition-related services. The medtech giant will pick up the Tel Aviv, Israel based company for an undisclosed amount. The acquisition is expected to close in Medtronic’...

7 Things That Have Medtech Companies Thankful in 2018

Does More FDA Oversight Equal Better Compliance?
Since 2007, FDA has increased its annual number of medical device inspections by 46% and has increased annual inspections of foreign firms by 243%. In that timeframe, the agency also helped establish the Medical Device Single Audit Program, which has i...

Looking at the AI Renaissance in Medtech
When I joined MD+DI nearly a year ago, I would hear smatterings about artificial intelligence and machine learning in medtech. But then something happened. By mid-February every other pitch I started receiving was AI-related.Conferences started delving...

Boston Sci Puts up $4B for BTG
Boston Scientific is back on the M&A trail. This time the Marlborough, MA-based company is offering $4 billion to acquire BTG in a deal set to close in the first half of 2019.London-based BTG has three key businesses, the largest of which is its Interv...

Diagnostics Are Helping Counter Antimicrobial Resistance, But More Work Is Needed
Antimicrobial resistance (AMR) threats to patient health are becoming more widely recognized and diagnostics manufacturers are making significant progress in combatting the overuse of antibiotics. There is still a lot of work to be done, however. A rec...

Embedded Hardware Technology: The Sure Cure for Counterfeiting
The issue of medical device and equipment counterfeiting has existed for decades and continues to escalate. Counterfeit medical devices and equipment enter the legitimate healthcare supply chain in many instances because buyers are seeking the best pri...

Oxford Startup Wants to Revolutionize Sensors
Oxford HighQ, a quantum technologies startup spawned from Oxford University, has received more than $2.5 million (£2.1 million) in seed funding to commercialize components of a quantum computing technology developed at Oxford University that can be use...

Pin-type Humidity Sensor Enabling Easy Replaceability
Sensirion presents the new pin-type relative humidity sen-sor SHT85 for easy replaceability in a wide range of applications

Using AI to Enhance Kidney Disease Detection
RenalytixAI is developing two approaches to help diagnose potential illnesses or complications with a patient’s kidneys. The company is working on an artificial intelligence-infused test for the early detection of kidney disease and will help in the ac...

4 Factors to Consider When Selecting a Spring Manufacturer
When you are working on a design for a new medical device, having the right mechanical components is important to ensure your device meets performance standards. Once you’ve determined the right mechanical components, your next step is to find the manu...

Abbott Nabs Approvals for DRG Invisible Trial System
Abbott Laboratories has nabbed approvals for a chronic pain treatment device that patients can try before getting an implanted version of the technology. The Dorsal Root Ganglion (DRG) Invisible Trial System now has CE mark and a nod from FDA. The Abbo...

Specialty Coating Systems to Exhibit at the Consumer Electronics Show
Specialty Coating Systems announces plans to exhibit at the Consumer Electronics Show (CES) in January 2019

Verily and Novartis Halt Glucose Detection Lens Work
When Alphabet’s Verily Lifesciences plunged into medtech the company took a deep dive. Some collaborations seemed futuristic and others were just natural. However, not all of the collaborations were going to be successful. And so, Verily, the former li...

Hearing Aid Tech Advances
For a well-established product like the hearing aid, the market is a dynamic one with incredible growth opportunities.“There’s only about a 20% penetration in the space,” reported Dave Olson, CEO of Elevated Technologies/Elevated Hearing. “A lot of peo...

Intracranial Hemorrhage Detection Software Receives FDA Clearance
“AI and machine learning are going to transform healthcare, as they have virtually every other industry they have touched,” said Gene Saragnese, chairman and CEO of MaxQ AI in an interview with MD+DI. “Our world is surrounded by algorithms that present...

Secant Group, LLC Milestone: 75th Anniversary
Secant Group announces that it has reached another milestone - its 75th anniversary

BioCardia Developing Comprehensive Approach to Treat Heart Failure
It can be a bit tricky when trying to put BioCardia’s cell therapy for heart failure in one specific category. Is the CardiAmp Cell Therapy a diagnostic, device, or a biologic? Perhaps it’s all of the above. The San Carlos, CA-based company’s president...

Edwards' Sapien 3 Ultra Valve Wins CE Mark
As expected, Edwards Lifesciences has secured a CE mark for its Sapien 3 Ultra device, but the company won't be able to release the new transcatheter aortic valve replacement (TAVR) system in Germany due to a recent preliminary injunction from Boston S...

Is Progress on MDR and IVDR Happening Fast Enough?
One year into the transition periods for the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), experts within the industry continue to express concern that more progress is needed to help companies prepare for the new re...

Vivasure Launches Large Bore Closure Device in Europe
Typically, transcatheter endovascular procedures require large bore femoral artery access. Vivasure Medical has come up with PerQseal, a device that can be used to close these large bore arterial punctures and return the artery to its natural state.“Pe...

Axonics Hopes to Surpass Medtronic in Sacral Neuromodulation Market
Axonics’ CEO Raymond Cohen wants to have the top spot in the sacral neuromodulation market when it comes to treating patients with urinary and fecal dysfunction. But to reach this position, Axonics is going to have some pretty stiff competition from on...

GE Recalls Nearly 1,000 Diagnostic Imaging Systems Due to Detachment Risk
Nearly 1,000 devices are included in a recall of GE Healthcare's Millennium Nuclear Medical Systems after the top detector of one system detached and fell onto the detector below.FDA said no patient injuries have been reported although there is a risk ...

How Digital Health Technologies Could Make a Difference
Digital technologies are already changing healthcare. Adherium’s Hailie sensor, for instance, which transforms a traditional inhaler into a smart device, is already reportedly demonstrating reductions in emergency hospital visits. Mark Jones, vice pres...

Supplier Stories for the Week of November 11

Additional I2C Address Available for Sensirion’s SDP800 Differential Pressure Sensors
Sensirion, the world’s leading manufacturer of high-quality environmental and flow sensors, presents new product variants of the SDP800 differential pressure sensor series. The SDP801-500Pa and SDP811-500Pa complement the product portfolio with an addi...

FDA Warns Against Off-Label Use of Implantable Pain Pumps
FDA is cautioning doctors and patients about the serious complications that can occur when using medications not approved for use with implanted pumps that deliver medication into the spinal fluid to treat or manage pain. Complications may include dosi...

How One Digital Health Company is Outsmarting Diabetes
There’s no doubt it will take a lot to curve the growing number of diabetes cases worldwide. But in order to deal with such a widespread problem, healthcare professionals will have to think outside of the box.One  digital health startup is actually tak...

Qosina Announces the Addition of Four New Board Members
Qosina Corp. is pleased to announce the appointment of four new board members

Virtual Reality Could Transform Prototyping
Medical errors are the third leading cause of death in the United States, with some studies citing numbers as high as 250,000 annually. Many studies have begun to increasingly look at misuse and adverse events associated with medical devices. While the...

What are Medtech CEOs Saying About the Currency Headwind?
mixture-69523__480.jpg Type Image Caption Multinational companies are moving into a challenging currency environment, but some companies appear to be better positioned than others ...

CATHTIP provides complete catheter solutions
CATHTIP and sister companies, Cath-Punch and Production Medical, unite to offer customers more robust, streamlined solutions for all their catheter product needs.

Cornea Problem? Precise Bio Can Print You Out a New One
Winston-Salem, NC-based Precise Bio, a regenerative medicine company that is working on advancing the use of bio-printed tissue and organs to patients, recently launched a dedicated ophthalmology business unit to support attainment of near-term opportu...

Merit Puts a Bow On Cianna Medical Acquisition
Merit Medical Systems has completed the acquisition of Aliso Viejo, CA-based, Cianna Medical. The South Jordan, UT-based company put an upfront payment of $135 million with potential earn-out payments of an additional $15 million for achievement of sup...

Philips Takes a Firm Stand in the DCB Market with ILLUMENATE
Medtronic is often cited as the leader in the drug-coated balloon market. The Dublin-based company has had a firm lead with its IN.PACT solution, a device used to treat peripheral arterial disease.However, there are a number of companies with new devel...

Your Monthly Download List
We've put together a list of the latest how-to medtech webcasts and whitepapers available on Qmed. You’ll find expertise on everything from design and business advice to materials and adhesives to manufacturing, packaging, and outsourcing. Click on any...

Abiomed’s Successful Pilot Study Leads to Pivotal Trial
Abiomed shares were down as much as 17% despite announcing positive data for its Impella CP. The Danvers, MA-based company presented the data from the 50-patient pilot trial at the American Heart Association annual conference in Chicago and said becaus...

AliveCor Heats up Mobile ECG Market with New Data
A research version of AliveCor’s mobile ECG technology could help rapid diagnosis and treatment of heart attacks, according to a study presented at the 2018 American Heart Association’s Scientific Sessions in Chicago.The ST LEUIS International Multicen...

Wireless Wearables: Challenges to Tackle
Wearable medical device usage by healthcare consumers has almost quadrupled in the past four years. It is up from nine percent in 2014 to 33 percent today, according to a survey released by Accenture. And the global market for these devices is projecte...

Cardiva Medical Has Strong Showing at AHA
Cardiva Medical’s vascular closure system has met its clinical endpoints in the AMBULATE randomized pivotal trial. The Santa Clara, CA-based company’s VASCADE MVP, a vascular closure system designed specifically for multi-access venous closure followin...

BTG Rides High on 2-Year Sentry Data at VIVA
Two-year results from BTG’s SENTRY trial paint a positive picture of the company’s bioconvertible inferior vena cava (IVC) filter. The London-based company unveiled the data at the Vascular Intervention Advances conference in Las Vegas.The prospective,...

Another Chance for Medtronic’s Renal Denervation Therapy
Medtronic has yet another chance to prove its renal denervation therapy can treat uncontrolled hypertension. The Dublin-based company has received FDA approval to begin a clinical trial to evaluate the Symplicity Spyral renal denervation system with pa...

CleanCut Technologies Announces New "Quick Tray™ with Pop 'N' Lock Technology™"
New Medical Device Packaging Solution Offers Strength and Stability without Rigid Packaging Materials

Device Implementation Sets the Stage for Successful Adoption
For clinicians, the use of new devices can represent significant solutions for their patients. However, if there’s a lack of education on the provider benefit or subpar training, a new vendor/provider relationship may fall flat before the device is abl...

Do You Need a “Warehouse of Stuff” Anymore?
Leonard Koren has been 3D printing for 20 years, and he’s seen a lot of progress over time. Future progress in manufacturing will depend upon more than just technology—a new mindset is needed, Koren believes.Koren started his first 3D printing company ...

Eximis Working on a New Surgical Platform
Eximis Surgical has secured $7.5 million in financing to help develop a surgical platform for the removal large specimens through small laparoscopic incisions. The financing was led by Questa Capital with participation from Venture Investors.The Louisv...

Starrett Introduces High Performance Automatic Vision System
New Extended Travel AV450 System offers Maximum Throughput and Versatility for a Wide Range of Repetitive, Larger Part Inspection Applications.

Supplier Stories for the Week of November 4

8 Things You Should Know about the EU MDRs
A recent survey by the Regulatory Affairs Professionals Society (RAPS) and KPMG revealed some shocking statistics. According to “The Race to EU MDR Compliance,”a solid majority (78%) of medical device companies responding to the survey do not have a su...

DexCom Continues to Shine Despite Growing Competition in CGM
Even though competition in the Continuous Glucose Monitoring (CGM) market is growing, DexCom continues to have momentum. The San Diego, CA-based company beat out 3Q18 expectations. Revenue for the quarter came in at $266.7 million vs. the consensus est...

HTI Plastics Announces Organizational Changes and Additions
HTI Plastics is pleased to announce that Brandon Boyer will transition to the position of Project Manager. 

Senseonics’ CGM Becomes More Effective with Latest FDA Nod
Senseonics Holdings has received a nod from FDA to make its Eversense Continuous Glucose Monitoring (CGM) system more accessible to patients. The agency’s approval allows qualified healthcare providers to be trained and certified to insert patients wit...

Bringing New Expertise into your Medtech Company

Intact Vascular Has Strong Data from TOBA II
One-year results from Intact Vascular’s Tack Optimized Balloon Angioplasty II (TOBA II) successfully achieved both its primary and secondary endpoints. The Wayne, PA-based company announced the results at the 15th annual VIVA conference in Las Vegas.Th...

Nevro Excels in Sales, but Misses on EPS Consensus
You win some, you lose some. Nevro might have been able to beat analysts’ estimates in sales, but the neuromodulation specialist failed to meet consensus of earnings per share for this most recent quarter.The Redwood City, CA-based company said 3Q18 EP...

Qosina Adds New Bonded Extension Lines to Its Inventory
Qosina introduces five new bonded, off-the-shelf extension lines

Sensirion Announces Its New Liquid Flow Sensor for Life Science and Analytical Instruments
Sensirion presents its latest liquid flow sensor, the SLF3S-1300F, at the Electronica and COMPAMED 2018 trade fairs. By combining Sensirion’s excellent 20-year track record in low and lowest flow rate sensing with a radically optimized mechanical desig...

Should You Develop Your Own Material Specification and Skip ASTM’s?
The basic format for an ASTM standardized metal alloy for medical uses includes a specification of the required elements as well as one or more undesirable elements for which there is a maximum allowable amount.For example, ASTM F2886, last approved in...

Are You Ready for the Factory of the Future?
There’s a lot of data tied up in medical device manufacturing processes—but it’s been challenging to capture and process this information from historically independent and disjointed machines and processes, say experts. In addition, skilled operators w...

NinePoint Keeps AI Offerings Fresh with IRIS
FDA has just given a nod to NinePoint Medical’s Intelligent Real-time Image Segmentation (IRIS) software upgrade for the NvisionVLE Imaging System. The Bedford, MA-based company said IRIS is an artificial intelligence-based platform for image feature s...

ResMed to Boost Portfolio with MatrixCare
ResMed is expanding its out-of-hospital software portfolio with the acquisition of MatrixCare. The San Diego, CA-based company will pick up MatrixCare for about $750 million. The deal is expected to close in ResMed’s 2Q19.MatrixCare, is a specialist in...

Surgical Robotics Market Due for a Shake Up?
For years, Intuitive has been recognized as the leader of the surgical robotics market. But there are more competitors on the horizon and the entry level for the surgical robotics’ market is far easier than it used to be.Roger Smith, MD, the Chief Tech...

Occlusion Test with Sprint^mD
The occlusion test is a vital test for medical devices to ensure that gases an other liquids flow correctly and that devices function as designed. In his latest blog, Uson's Joe Pustka discusses how the test works when using the new SprintmD leak and f...

Breaking Through the Bias: Debunking Common Misconceptions About Usability Studies
Usability studies—do they have purpose? For healthcare, it’s all too common to think of usability studies as a box to check to satisfy regulatory requirements. But by doing this, companies leave good information on the table, and they don’t explore the...

Halfway to the New European Medical Device Regulation, U.S. Manufacturers Feel the Pinch
The regulators are coming! The regulators are coming!In the swirling waters of the global economy, it can be hard to keep up with every new development. However, this October marks an important regulatory milestone that should not pass by unnoticed. Wh...

Illumina Shows That Big Medtech Deals Are Far from Over
Just when it looked like the year would end without another mega-merger, Illumina has swooped in to acquire its rival, Pacific Biosciences (PacBio), for $1.2 billion.The move would solidify San Diego, CA-based Illumina’s position in the genetic sequenc...

Sensirion Particulate Matter Sensor Is Now Available Globally
The SPS30 particulate matter sensor is now available worldwide through Sensirion’s distribution network.

How Smart are Your Design Inputs?
Design inputs, and design controls in general can be challenging to get right, according to Jesseca Lyons, a customer success expert at Greenlight Guru."There's almost an art to it.  I find that most of the people I talk to struggle the most with how t...

New Blood Test Makes the Autism Picture a Bit Clearer
NeuroPointDx is launching a blood plasma-based test that might be able to give a clearer picture of the prevalence of autism in children. The Madison, WI-based company said the NPDX AA Test, identifies metabolic subtypes associated with the autism spec...

One of the Top 25 Medtech M&A Targets Has Strong Quarter
Abiomed dominated in its recent quarterly earnings. The Danvers, MA-based company posted revenues of $181.8 million topping analyst consensus of $175.2 million.The cardiac device maker also had $1.09 per share edging out analysts’ consensus of 74 cents...

Another Hold up for NxStage’s Merger with Fresenius
Fresenius Medical Care’s $2 billion acquisition of Waltham, MA-based NxStage Medical has been delayed yet again. The Bad Homburg, Germany-based company made plans to pick up NxStage in August of 2017 and the deal was supposed to close sometime this yea...

How Are Engineers Actually Using VR for Human Factors Review?
We've been hearing for some time now that virtual and augmented reality technologies are poised to revolutionize medtech, but can a VR system actually help R&D teams develop a medical device? It absolutely can, according to engineers at Cincinnati, OH-...

How Video Games Can Be Used to Improve Diagnosis and Treatment Methods
These days when it comes to improving the process of diagnosing and treating patients, medtech companies are always looking for explore the unexplored. Level Ex, an innovative medical technology company based out of Chicago, may be taking the most uniq...

New York State Initiative Hopes to Stop the Spread of Super Bugs
Each year in the United States, at least two million people become infected with antibiotic-resistant infections--so-called super bugs. And at least 23,000 of those people will end up dying from them, according to the Centers for Disease Control and Pr...

Say Hello to Hospital’s New Fully Autonomous Service Robot
Swisslog Healthcare, a global supplier of solutions and services for material transport, announced earlier this month the full market launch of their flagship technology, the Relay robot. The new autonomous service robot was designed for deployment in ...

98point6 Uses AI to Help Redefine Primary Care
98point6 is on a mission to make primary care more efficient with the use of artificial intelligence. The Seattle, WA-based company said it raised $50 million in a series C round, bringing the total amount raised to $86.1 since the company’s inception ...

Amazon’s Latest Move in Medtech Is a Big Deal
Amazon is continuing its deep dive into the healthcare market. This time the Seattle, WA-based company is teaming up with Arcadia, a consultancy group, to launch an exclusive brand of consumer-use medical devices for diabetes and hypertension managemen...

Ghosts of Medtech: What Ever Happened to These 7 Medical Devices?
ghost-1132323__480.jpg Type Image Caption <p>Sometimes even seemingly good ideas just don't pan out. Read on to see seven medtech products that once held a lot of promis...

Supplier Stories for the Week of October 28

New Surgical Mesh Is 'There When You Need It, Gone When You Don't'
Let's face it, "mesh" has become a four-letter word in more ways than one, given the number of long-term complications and lawsuits surrounding surgical cases in which mesh was used. But that doesn't mean that doesn't mean that mesh doesn't have its pl...

What Will Be Your Next Move in the In Vitro Diagnostic Space?
When it comes to in vitro diagnostic (IVD) technologies, medical device and diagnostic companies have been chomping at the bit to produce the next big innovation. The last few years have seen a surge in IVD technologies in the market, as device makers ...

Winning Competition Entry Could Improve Documentation Process for Administering Drugs
Vetter, a global contract development and manufacturing organization based in Ravensburg, Germany, has announced the winner of its first Open Innovation Challenge — Injection 2.0. The competition, which kicked off in June, brought together four differe...

Bringing Precision Diagnostics Home
Patients living with autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus (SLE), or multiple sclerosis must see their health practitioners frequently to check the progression of their conditions and their responses to therapie...

Should Stryker Worry About Zimmer's New Robotics Offering?
Stryker's Mako Total Knee offering continues to gain traction and drive growth for the Kalamazoo, MI-based orthopedics company, but the company faces imminent competition in the space from Warsaw, IN-based Zimmer Biomet.During Stryker's third-quarter e...

Zimmer Has to Reduce the Size of Its Portfolio, CEO Says
Zimmer Biomet is making progress toward the company's supply recovery goals, but CEO Bryan Hanson says he is still not happy with where the company is at. "The fact is, we need to continue to focus on bringing up our service levels to our customers. We...

Boston Scientific Keeps Us Guessing on Recent Legal Victory
Boston Scientific has a big decision to make in Germany, and the clock is ticking.Earlier this week, a German court sided with Boston Scientific in a patent case involving its transcatheter aortic valve replacement technology. The court decided that Ed...

Could Reimbursement for AI Solutions Really Be That Tricky?
It would be almost impossible to ignore the recent artificial intelligence explosion in healthcare. There have been numerous approvals, clearances, and companies that are developing various solutions with AI capabilities. Some firms have taken the fore...

List of Medtech Divestitures Is Quickly Growing
Sometimes it just comes down to finding the right fit. That seems to be the story in the medtech industry these days as companies are stepping up to acquire divested assets. The latest chapter in the divestitures story comes from Becton Dickinson & Co....

Supplier Stories for the Week of October 21

5 Steps to Move 3D Printing Processes from Prototyping to Production
Advances in 3D printing could make medtech mass customization a reality. Matt Sand, president of 3DEO, will discuss the role of 3D printing in medtech in the MD&M Minneapolis session, “3D Printing: The Journey from Prototyping to Production to Metal 3D...

Expect Boston Scientific to Keep Rounding Out Its Portfolio with M&A
 Boston Scientific has been on quite the shopping spree in 2018. The Marlborough, MA-based company has announced eight acquisitions since the beginning of the year, plus a hefty investment in Millipede, which is likely to lead to an acquisition within ...

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Top 10 Medical Innovations for 2019

A Truly Epic CEO Rocks the Cleveland Medical Innovation Summit
When Judy Faulkner launched Epic Systems from a Wisconsin basement in 1979, the medical software company was worth about $70,000. Speaking at the Cleveland Clinic Medical Innovation Summit, Faulkner told the audience about the firm's "Epic" journey. Ac...

GW Silicones Turns 10
GW Plastics Celebrates 10th Anniversary of GW Silicones

Is Primary Care Really Under Siege?
A panel during the Cleveland Clinic 2018 Medical Innovation Summit addressed the possible future of primary care. The concept of the primary care physician is under siege from a number of things. An uneven payment system, millennials seeking out other ...

Rugged 100 / 150 Watt Power Supplies in Miniature Open Frame Package
• IEC/EN/UL 609501 Approvals (ITE)• IEC/EN/ES 60601-1 3rd Edition Approvals (Medical)• EMC compliance to EN55011 & IEC60601-1-2 4th Edition• Risk Management file Per ISO 14971• 12V Aux Fan Output (150W models)• Max 0.3W No Load power consumption (ErP R...

Consider the Most Probable Number Method for Bioburden Testing
The most probable number (MPN) bioburden test method can be a valuable tool for determining bioburden counts when the typical bioburden test methods are problematic on a particular product or when a test needs to detect low levels of bioburden.Common b...

Is Your Company’s IP a Cybersecurity Risk?
Every organization knows its intellectual property is incredibly valuable — potentially it’s the most valuable data any company has. For manufacturers in the medtech space, it’s often the lifeblood of the company. IP is also one of your most vulnerable...

Medtech Mourns the Loss of Earl Bakken: Visionary, Humanist, Pioneer
Thousands of patients, clinicians, and medtech colleagues took to Twitter on Monday to honor the legacy of Earl Bakken. The co-founder of Medtronic and inventor of the first wearable external pacemaker, Bakken died Sunday in Hawaii at age 94.“All of us...

SetPoint Strikes a (Vagus) Nerve With Arthritis Patients
SetPoint Medical is looking to shake up the way rheumatoid arthritis (RA) is treated. The Valencia, CA-based company has completed enrollment for a pilot IDE that will evaluate its bioelectronic device to treat patients with drug refractory RA.“[Enroll...

UDI: 5 Opportunities You May Not Have Considered
It may only be three letters, but for some manufacturers, UDI is a four-letter word. There are others who see the regulation as an opportunity to better understand product performance, speed up regulatory approval and coverage decisions, and improve th...

Who Stole the Giant Inflatable Colon?
The University of Kansas Cancer Center is asking for the public's help to crack the case of a stolen colon. Well, a stolen inflatable colon, that is. The 150-pound, 10-foot-long inflatable colon was taken from the back of a pickup truck last week and i...

Abbott's HeartMate 3 Pump Can Now be Offered as a Destination Therapy
As if Abbott Laboratories hasn't had enough to celebrate this year, the company just scored FDA approval for the use of its Heartmate 3 pump as a destination therapy. The approval, which CEO Miles White hinted about earlier in the week, is a big win fo...

Hope for Broken Hearts
Biolife4D has achieved a milestone in its ultimate quest to develop human organs for transplant. The company recently announced that it has developed a cardiac patch using a highly specialized 3D printer designed to protect living cells during the prin...

More Change Is Afoot at NuVasive
NuVasive is raising eyebrows once again with the unexpected announcement that CEO Greg Lucier will be replaced by J. Christopher Barry, effective Nov. 5. Lucier will continue to serve the San Diego-based spine company as chairman of the board. Mike Mat...

Abbott-Alere One Year Later: Was It Worth All the Fuss?
It's hard to believe it's been a full year since Abbott closed its acquisition of Alere, considering what a contentious deal it was and how hard Abbott fought last year to get out of it. When the acquisition finally did close, an MD+DI headline asked: ...

Atrium’s Biosurgery Division Changes Hands Yet Again
Getinge’s subsidiary, Atrium Medical will divest its biosurgery business to HJ Capital 1, the parent company of SeCQure Surgical for an undisclosed sum. The deal is expected to close sometime in 4Q18.Göteborg, Sweden-based Getinge added the biosurgery ...

Exact Sciences Set to Acquire Biomatrica
Medtech acquisitions remain fast and furious today as Exact Sciences is acquiring sample preservation specialist Biomatrica. The deal between the two is for an undisclosed sum.San Diego-based Biomatrica's sample collection tubes, which contain propriet...

Abbott's Growth is Impressive, but What about That Elephant?
 Abbott Laboratories has had another stellar year in terms of new product launches and strong growth drivers across the company. In fact, the company's pipeline may be the strongest its ever been, thanks to products like the FreeStyle Libre glucose mon...

Applying Quality Management Best Practices for Medtech
Building a reputation for world-class quality and compliance is essential for medical device manufacturers to stay in business and grow. But doing so is often a complex and expensive process. Still, savvy companies are thriving even as newer regulation...

Gauss Uses AI to Accurately Measure Blood Loss
Gauss Surgical is using machine learning and artificial intelligence for the early recognition of postpartum hemorrhage. To do this, the Los Altos, CA-based company has developed Triton, a monitoring solution that helps physicians and clinicians accura...

Making Injection Molding More Efficient
When it comes to injection molding, traditional manufacturing methods involve a very calculated process that requires molders to re-validate parts every time a mold is going to run in a different machine. This has become a major design headache for dev...

Nordson Corporation Acquires Clada Medical Devices to Expand Balloon Catheter Engineering Capabilities
Clada Will Become Part of the Nordson MEDICAL Product Line

ReWalk Expected to Miss 3Q18 Expectations
Earlier this week, ReWalk Robotics revealed it would miss the mark for its 3Q18 earnings coming in about 6% lower than it did this time last year. The exoskeleton developer said it expected to bring in sales of $1.6 million for 3Q18, which misses analy...

Should You Employ a Cobot?
Collaborative robots can often take on repetitive tasks, freeing up skilled operators to focus on more-complex tasks. “A robot never gets sick, never gets tired, yet is flexible enough to be moved around a manufacturing plant based on plant demand,” Da...

Supplier Stories for the Week of October 14

Interrupting the Medtech Status Quo
As a facial trauma surgeon, Dr. Alan Johnson hated using wires and arch bars to immobilize jaws to help heal jaw fractures. “This is commonly known as ‘having your jaw wired shut,’ "Johnson told MD+DI. “It’s miserable for patients, time consuming and r...

J&J’s Device Unit Fails to Meet Sales Expectations
Johnson & Johnson beat Wall Street expectations in 3Q18, fueled mostly by its pharmaceutical unit, but that doesn’t mean every business from the New Brunswick, NJ-based company is firing on all cylinders. J&J noted its medical device unit was a bit beh...

What's Next for Bioresorbable Scaffolds?
Even with new data, the future of bioresorbable scaffolds remains in flux. At TCT 2018 in September, Reva Medical and Abbott Laboratories painted differing pictures with their respective bioresorbable scaffold studies. What now?Dr. Lukasz Koltowski fro...

25 Medtech Startups You Need to Know

Compamed 2018: Raumedic to Spotlight Silicone Processing and Wire Coating
With the slogan "All from one source", the medical technology manufacturer Raumedic will present its wide range of polymer solutions for the medical and pharmaceutical industry from November 12 to 15 at Booth F28 in Hall 8a at Compamed. The company’s b...

ConvaTec CEO Departs Suddenly as Company Slashes Profit Forecast
ConvaTec shares plunged 33.10% ($74.20) Monday after the company slashed its revenue guidance and announced the departure of CEO Paul Moraviec.The advanced wound care company said Moraviec informed the board that he "wishes to retire." He stepped down ...

Microsoft Dives Deeper into Genomics with AI Collaboration
Microsoft is looking to strengthen its commitment to genomics and is partnering with Genoox, a healthcare technology company, to accomplish this goal.The collaboration will combine the performance of Microsoft Genomics’ Azure Cloud with Tel Aviv, Israe...

Zimmer Biomet to Use Apple Watch in Clinical Trial
Can the Apple Watch and iPhone really be effective tools in healthcare? That question might be answered sooner than we think. The Cupertino, CA-based company is teaming up with Zimmer Biomet by using the Apple Watch and iPhone to change the patient jou...

Abiomed Responds to MedSun Report on Two Impella Pumps
Editor's note: This story has been updated from the original story to include comments from Abiomed.A report published through FDA's medical product safety network (MedSun) database describes two issues that involve Abiomed's Impella heart pumps. Howev...

Do Minutes Count in the Fight Against Antimicrobial Resistance?
Abbott claims its point-of-care ID NOW testing platform offers the fastest-ever time to influenza A and B test results. Formerly called Alere i, ID Now can provide results in 13 minutes or less, with positive results available in about five minutes.Dr....

Medtronic Issues Fix to Address Cybersecurity Vulnerabilities
Medtronic has issued a software update to address a safety risk caused by cybersecurity vulnerabilities associated with the Internet connection between two models of CareLink programmers used to download software from the company's software distributio...

Vital Therapies Evaluating Options After Clinical Trial Failure
Vital Therapies is reviewing strategic options including a potential sale or merger of the company, according to an SEC filing. The decision to review its position comes after the San Diego-based company failed to meet the endpoints in a clinical trial...

What Could the Midterm Elections Mean for Medtech?
Speakers at The Medtech Conference from AdvaMed shared their thoughts about the midterm elections in “DC Download and Midterms Preview,” moderated by Greg Crist, executive vice president, public affairs, AdvaMed. The panel included Charlie Dent, former...

iCAD’s AI Solution Has Exceptional Results in Study
iCAD’s digital breast tomosynthesis cancer detection software could make a big splash at the upcoming Radiological Society of North America meeting if recent study results are any indication. The solution will also be displayed at The European Society ...

Supplier Stories for the Week of October 7

What Does It Take to Develop a VR Solution in Healthcare
Technology is changing the face of healthcare as we know it. virtual reality and augmented reality that once were associated only with game and film industries are now becoming a real game-changer in healthcare. Gone are the days when students practice...

4 Reasons Medtech Outsourcers Should Consider Cold Forming
Technavio predicts the global medical device manufacturing outsourcing market to grow at a CAGR of almost 12% during the period 2018-2022. Medical device outsource firms and contract manufacturers can expect increased demand as OEMs press to reduce the...

5 Fundamental Flaws of the Medical Device Tax
The medical device tax hurts doctors, patients, and manufacturers, according to a new study released today by the San Francisco, CA-based think tank, the Pacific Research Institute."As the congressional session winds down, Congress has some unfinished ...

Cardialen Closes $17M Series B
Cardialen closed a $17 million Series B investment led by RiverVest Venture Partners, along with Qiming Venture Partners, HBM Healthcare Investments and Cultivation Capital.The Minneapolis-based company said it is developing the Cardialen unpinning ter...

Is 2018 Boston Scientific’s Biggest Year Ever?
Is there any other company in the medtech industry killing it like Boston Scientific is killing it right now? Solid performance and numerous acquisitions have pretty much been the story behind the Marlborough, MA-based company during 2018. (I think we’...

Add These Medtech Resources to Your Monthly Download List
You’ve read the latest headlines on medtech movers and shakers. You’ve seen the stories on new medical devices and on regulatory developments. But have you perused the latest how-to webcasts and whitepapers from leading suppliers in the space?There’s a...

AdvaMed Backs Wright Medical in Hip Liability Case
A case stemming from a hip implant lawsuit against Wright Medical has caught the attention of several professional associations, including AdvaMed, as the outcome could have broad implications for the medical device industry.The lawsuit makes a strict ...

Could 2018 Really Be the Year of AI in Medtech?
Has there really been another topic in medtech this year that has generated more attention than Artificial Intelligence? There have been numerous approvals, clearances, and even in some cases praise from regulatory bodies about AI-based medtech.MD+DI h...

Could Publicly Funded Medtech Face Price Controls in NJ?
New Jersey Senate Bill 977 (S977), which seeks to prohibit “excessive charges for drugs developed by publicly funded research,” includes “other health care technology” and could therefore impact medtech.Dean J. Paranicas, president and CEO of the Healt...

Linemaster Launches New Website
Linemaster introduces our brand new website that launched in August of 2018.

Get Ready for These 4 Medtech Shifts
Healthcare has historically focused on treating the chronically ill and diseased populations, but things are changing, and it is a “global shift,” Sowmya Rajagopalan, industry principal of Frost & Sullivan, told attendees at The MedTech Conference. “Pa...

8 Medtech Manufacturing Trends You Need to Know
stock-1682870__480.jpg Type Image Caption <p><strong>Manufacturing's Hiring Dilemma </strong></p><p>The manufacturing industry is on an upward gr...

Continuous Quality: FDA’s Goal for the Case for Quality Program
About five years ago, when FDA started looking at the number of recalls and warning letters to medical device manufacturers, the agency realized that no matter what it seemed to do to try and make things better from a compliance perspective, those numb...

FDA Congratulates Itself on Apple’s New Medical Apps
In a recent blog post, FDA’s Commissioner Dr. Scott Gottlieb found great merit in the agency’s handling of Apple’s two “marketing authorizations” for medical apps to run on the Watch Series 4. These authorizations were via the DeNovo route to market. T...

Self-Fitting Hearing Aid Receives Nod from FDA
A newly-approved device could change the way patients manage their hearing loss. Last week, FDA greenlit the Bose Hearing Aid, which is called the first such technology that doesn’t require the assistance of an audiologist or healthcare providers.The h...

Teleflex Makes an ‘Essential’ Acquisition
Teleflex is making a move to expand its presence in the structural heart and endovascular aneurysm repair markets. To do this, the Wayne, PA-based company is acquiring Essential Medical for an undisclosed sum.Essential Medical has developed and receive...

Bristol Instruments Increases the Measurement Range of Its Optical Thickness Gauge with Addition of New Model 137LS
Bristol Instruments expand its family of non-contact thickness gauges with addition of the model 137LS Optical Thickness Gauge

Can Medtech Manufacturing Benefit from Deep Learning?
Given medtech’s needs for high levels of quality and precision, machine learning could be put to good use in medical device manufacturing. One particular type of machine learning called “deep learning” could offer particular benefit as it could enable ...

Owlstone Advances Breath Biopsy Platform with $50M Round
Owlstone Medical has raised a total of $50 million for its Breath Biopsy platform. The Cambridge, England-based company said it has raised about $73 million since it was founded in 2016.The funds have been raised to expand commercial opportunities in p...

Panel Sheds Light on DBS Electrode Design Concerns
Traditionally there has always been a great deal of conversation surrounding deep brain stimulation (DBS) systems. However, this just hasn’t been the case for one of the most important components of the technology – the electrode. A panel at MD&M Minne...

Raumedic Supports Project against Pediatric Brain Tumors
The Munich-based Care-for-Rare Foundation received a donation of 5,000 euros from medical technology company Raumedic. On September 25, the polymer specialist presented the donation check to the charitable organization, which has set itself the task of...

Supplier Stories for the Week of September 30

Prioritizing Patients in Push Toward Value-Based Care
Previously, we discussed how medtech companies can prepare for the transition to value-based care. Specifically, these organizations need to start going beyond just providing medical devices and products to their customers and focus more on providing c...

Will Single Port Robots Revive the Perineal Radical Prostatectomy?
Designing a robotic-assisted surgery system that brings four robotic arms through a single 25mm port was far from an easy feat for Intuitive Surgical. In a recent interview with MD+DI, Intuitive's chief operating officer described it as a tremendous le...

What Could Go Wrong If Designers Don’t Understand Manufacturing?
Design for Manufacturability (DFM) entails designing products so that they are optimized for production, Steve Santoro of MICRO told MD+DI. “DFM is extremely important and allows potential problems to be identified and addressed during the design phase...

Boston Scientific Is Closing Cultural Gaps from Top to Bottom
It's easy for corporations to spin rhetoric about diversity and inclusion but in much of corporate America – and especially in medtech, as MD+DI has previously reported – these terms are just that: rhetoric.The good news, however, is that at least two ...

Is Stryker on a Buying Spree That Could Rival Boston Scientific’s?
It really seems like Stryker is starting to behave a lot like Boston Scientific when it comes to making acquisitions. In the last few months, the Kalamazoo, MI-based company been hitting the M&A trail fast and furious – which is eerily similar to what ...

Micro Pump to Deliver Parkinson’s Treatment, with More in the Pipeline
Sensile Medical has custom developed a wearable micro pump for a Parkinson’s disease treatment from a European pharmaceutical company. Sensile Medical is a subsidiary of Gerresheimer, and the project is just one of many, which also includes a diabetes ...

Overcome These Challenges When Manufacturing Plastic Medical Devices
Plastics offer many advantages, from flexibility and simplicity to cost-effective manufacturing. However, device makers do encounter design and manufacturing challenges that can create roadblocks.Shantanu Shivdekar believes that plastic materials have ...

Prepping for Value-Based Care in the Medtech Space
Value-based healthcare greatly depends on improving patient outcomes at lower cost, and the ability of healthcare providers to impact quality of care measures, such as reducing hospital readmissions or improving preventative care.Medtech companies need...

Sprint^mD Leak Tester – The Check Valve Test
Uson's new SprintmD leak and flow tester can perform a sensitive and difficult test on check valves. The downstream sensor option enables the tester to precisely determine the cracking pressure of even small valves with accuracy. The test is described ...

Checkpoint Reels in $9M in Financing Round
Checkpoint Surgical said it has completed a$9 million financing round. The Cleveland-based company is a specialist in nerve protection and repair. The financing was led by Mutual Capital Partners, existing backers included First Analysis, a growth equi...

GW Plastics Celebrates 10th Anniversary of GW Silicones
Leading Contract Manufacturer Grows Silicone Tooling and Molding Operation with Strong Leadership and New Technologies, Eyes Global Expansion

Is This the Future of Healthcare?
We’ve all heard the saying, “prevention is the best medicine,” and yet preventable illness continues to impact patients. Could a new approach to primary care employing advanced medical technology such as high-tech sensors make a difference in wellness?...

Is Your Design Revolutionary or Evolutionary?
Not all new medtech designs are revolutionary, and that’s ok. Incremental advancements evolving from predicate devices—also known as evolutionary designs—could very well delight users and provide companies with a competitive edge. Speakers at the upcom...

LeMaitre Vascular Expands Clot Management Offerings with New Deal
LeMaitre Vascular said it has acquired the vascular clot management business of Applied Medical Resources Corp. for $14.2 million, of which $11.0 million was paid at closing and $3.2 million will be paid in two post-closing installments.As part of the ...

New Starrett Digital Gages put force measurement in the palm of your hand or on a stand
Versatile, Innovative Digital Force Gages can be used Handheld or Mounted on Starrett Force Testing Stands.

SEC Strikes Again: Stryker Coughs Up $7.8M to Settle FCPA Violation Charge
The SEC has charged Stryker with violating the Foreign Corrupt Practices Act (FCPA), marking the second time the agency has brought an FCPA action against the orthopedic device company.Stryker agreed to settle the charges and pay a $7.8 million penalty...

Hologic Finds Focal Point in Breast Health with New Acquisition
Hologic has signed an agreement to acquire Focal Therapeutics for about $125 million in cash to boost its breast health offerings. The deal comes hot on the heels of the Marlborough, MA-based company announcing it would acquire Faxitron Bioptics, anoth...

IDx Moves from Angels to VC Investors with $33M Series A
Since 2010, IDx had been funded mostly by angel investors. But now the Coralville, IA-based company, which obtained a nod from FDA in April for its artificial intelligence (AI) solution to detect diabetic retinopathy, has received funding from venture ...

Supplier Stories for the Week of September 23

What Does the Future Hold for Robotic Surgery?
It's hard to believe it's been nearly two decades since Intuitive Surgical launched its first da Vinci system. And yet, in many ways, the field of robotic-assisted surgery is still in its infancy."There's no university program on robotic-assisted surge...

Device Cybersecurity: For Better — and Worse? The Very Connected World of Medical Devices
The Internet of Things is no longer a faraway dream, like jet packs and cities teeming with self-driving cars. IBM predicts that the burgeoning web of hardware, software, electronics, and sensors will encompass 50 billion devices by 2020, more than 60 ...

New Strategy Board Member at Raumedic
Stefan Seuferling joined the Executive Board of Raumedic AG mid-September to strengthen the company’s management team. Together with his Executive Board colleagues Martin Schenkel, Thomas Knechtel and Bernhard Kernen, the 45-year-old is helping lead th...

Proscia to Change Cancer Detection Paradigm with AI
Digital pathology specialist, Proscia has raised about $8.3 million of a series A round. The Philadelphia-based company has developed a software that uses artificial intelligence  (AI) to change the way cancer is diagnosed.Proscia’s digital pathology p...

What Can Medtech Do with Medicare Data via Blue Button 2.0?
"In the era of artificial intelligence, machine learning, and precision medicine, fax machines continue to be the go-to technology for providers transmitting health information."That's Centers for Medicare and Medicaid Services (CMS) Administrator Seem...

Will Medtronic's New Spine System Be 'Infinitely' Better for Workflow?
Medtronic would have been hard pressed to pick a more appropriate name for its new posterior cervical spine surgery system. The company launched the Infinity Occipitocervical-Upper Thoracic (OCT) System this week at the annual North American Spine Soci...

BeBop Sensors Wants to Power the Next Generation of Smart Fabrics
BeBop Sensors, a company that develops smart fabric sensors, aims to change the world of wearable smart devices and fabrics with its new line of sensor technologies that have been specifically designed to bend and stretch while being worn on the body. ...

Can a Device Be Safe and Effective When FDA Recommends to Not Use It?
Legally marketed medical devices are supposed to be safe and effective in accordance with FDA’s mandates and procedures. Devices that are already being marketed and are then found to not be safe and effective should be the subject of recalls or market ...

How to Get to Market Quickly, Without Driving Your Team Crazy
Project engineers often spend weeks, if not months, waiting for management to formally approve a new project. Then, as soon as the green light is on, so is the pressure."The minute our executives say go and everyone is excited, a week later they come d...

HTI Plastics Hires Tee Welton as Director of Operations
HTI Plastics is pleased to announce the hiring of Tee Welton, who was recently hired as the Director of Operations. 

Medtech Needs to Get Serious About Investing in Digital Health
Nearly a year ago, MD+DI asked the question, is digital health making an impact on healthcare? Now, a report from Ernst & Young titled Pulse of the Industry is answering that question and points out that if medtech companies don’t make significant inve...

Boston Sci’s Eluvia Set to Make Impact in DES Market with PMA
Shares of Boston Scientific were slightly up on Monday (about 1.44%), as the Marlborough, Mass.-based company announced it received FDA approval for the Eluvia Drug-Eluting Vascular Stent System. The stent was specifically approved to treat patients su...

Fired MiMedx Execs Say the Company's Investigation 'Spun Out of Control'
For the first time since being terminated from their top positions at MiMedx, former CEO Parker "Pete" Petit and former COO William Taylor spoke out today about the investigation that led to their dismissal earlier this year.In February, MiMedx postpon...

Alydia Tackles Postpartum Hemorrhage with Device
A small startup is developing a device aimed at treating and preventing maternal bleeding. Menlo Park, CA-based Alydia has raised $10 million in a series B round to help it get the technology past clinical trials and onto the market in the U.S. The tec...

Can Cross-Pollination Improve Medtech Manufacturing Processes?
In a panel discussion at MD&M Minneapolis, experts will offer their insights on cross pollination, a process whereby those in the manufacturing arena can draw upon another industry’s methods to improve their own. “I would define cross-pollination as us...

Cardiovalve Makes Crucial Move in TMVR Market
Another company is trying its hand at the emerging transcatheter mitral valve replacement space – which could someday outpace TAVR. OR Yehuda, Israel-based Cardiovalve said it has commenced the AHEAD US Multicenter Study, which will test the safety and...

Cleancut Technologies’ “Dual Hoop Catheter Disk” Honored with Dow’s Gold Award for Packaging Innovation
CleanCut Technologies’ Dual Hoop Catheter DISK honored with Dow award

Could One Hour a Day Make the Foot Pain Go Away?
More than three-quarters of Americans have suffered from foot pain, the American Podiatric Medical Association reported a few years ago.Tendonitis and plantar fasciitis are common complaints, and treatments can include stretching and splints. Patients ...

Medtronic and Mazor will Tie the Knot in a $1.6B Deal
Medtronic made a big move back in May 2016 by inking a major multi-phased strategic and equity investment agreement with Mazor Robotics. Today the pair made that relationship even more official by announcing that Medtronic will acquire Mazor.The cash d...

Could a New Biosensor Be Able to Smell Cancer?
Researchers from Aromyx Corp. announced this month that the company’s flagship technology, the EssenceChip, will be made available to select partners by the end of this year. The new biosensor technology was designed to work with a digital platform tha...

Intuitive Surgical Could Help Usher in a New Era for Medtech
More than a decade ago Amazon recognized that it needed mass-cloud computing power, but didn't believe there was a third party service available to meet their needs, so they built their own cloud computing infrastructure. The online retailer also reali...

MeMed Looks to Distinguish Between Bacterial and Viral Infections
Bacterial or viral infection, that is the question. Haifa-Israel based MeMed Diagnostics is developing a point-of-care platform and immune-based test that will one day be able to provide answers. Such a test could help with the overuse and underuse in ...

Supplier Stories for the Week of September 16

7 Key Events That Solidified the Liquid Biopsy Market

How a $2M Grant Could Change the Way Autism Is Diagnosed
Early treatment of autism spectrum disorder (ASD) can significantly improve the lives of affected children and their families, but diagnosing the disorder is often a challenge. A company in Syracuse, NY has developed an epigenetic test that could facil...

Is AI the Key to Diving Deeper into Images and Pathology?
In a tale of two studies, it appears artificial intelligence is helping researchers analyze cells in ways that weren't possible before.In one study, published this week in Nature Methods, scientists at the Allen Institute in Seattle, WA used machine le...

MedAutonomic Has Successful Implant of Phoenix
MedAutonomic has made significant progress with its brain neuromodulation technology. The Silicon Valley and Venice, Italy-based company said it had successfully implanted the Phoenix device into the stomach wall of a human through a digestive endoscop...

Single-Touch Labeling: The Answer to EU MDR?
The journey to adoption of Europe’s Medical Device Regulations (EU MDR) begins with understanding what’s changing—and when—and then establishing whether current systems and processes are sufficient to satisfy the new regulatory requirements. With the n...

Smalley Wins GM Supplier Quality Excellence Award for 6th Consecutive Year
Smalley presented with the 2017 General Motors Supplier Quality Excellence Award

Can LivaNova Succeed Where Others Have Failed in HF?
LivaNova continues to live up to the promise it made to shareholders that it would focus more on its neuromodulation and cardiac surgery businesses. Through the VITARIA neuromodulation technology, the London and Houston, TX-based firm is fulfilling tha...

Medtronic Will Study TAVR in Low-Risk Patients with Bicuspid Valves
Indication is to the transcatheter aortic valve replacement (TAVR) market as location is to the real estate business.Although TAVR already represents a $3 billion market globally, the leading TAVR companies say the currently approved indications barely...

Navigating the World of Digital Health Products
A presentation at MD&M Minneapolis aims to help medical device manufacturers and newcomers alike overcome the challenges of designing digital devices.“Scale and cost and prevalence of consumer-oriented technology like Wi fi and Bluetooth and cell phone...

XACT Brings in Funding and CE Mark for Robotics Navigation System
XACT Robotics has received CE mark for its robotics navigation steering system. On top of that, the Caesarea, Israel-based company has raised about $5 million in a series C round. How’s that for being efficient?The company said the funds will mainly be...

Are You Really Ready For MDR?
Audrey Turley doesn’t shy away from speaking about biocompatibility topics related to medical devices. Turley serves as a senior biocompatibility expert for Nelson Labs. The Salt Lake City, UT-based lab serves as an independent consultant that can help...

Breast Implant Study Should Be Taken with a Grain of Salt, FDA Says
A study linking silicone gel-filled breast implants with several rare diseases should be viewed with caution, according to FDA.The authors of the study, published last week in the Annals of Surgery, say they looked at data from nearly 100,000 breast im...

Finding Lung Cancer Outside the Airways Just Got Easier
Diagnosing solitary lung tumors located outside of a patient's main airways has long been a challenge, but evidence is building around a technology designed to improve access to such tumors.According to data unveiled this week at the European Respirato...

Venture Heat Warms up Wearables with New FDA Nod
On Monday, Los Alamitos, CA-based Venture Heat said it had received FDA clearance for its Infrared Heat Therapy Pain Relief using Far infrared Rays (FIR). FIR heat therapy is a type of low-energy therapy that takes advantage of heat generated by waves ...

6 Products that Could Help Tackle Pain

FDA Approves First New Device for Heart Vessel Tears in 17 Years
Cardiologists have a new tool for handling a rare but potentially life-threatening complication during percutaneous coronary intervention (PCI) procedures.FDA approved Biotronik's PK Papyrus Covered Coronary Stent System as a treatment for tears in the...

Financing Allows Endotronix to Take Big Step in Treating HF
Endotronix just received a huge shot in the arm when it comes to supporting the commercialization of its heart failure system. The Lisle, IL-based company just closed on a series D financing round of $45 million.This financing supports the commercializ...

Just Where Does Apple’s New ECG Fit into the Market?
The inclusion of two heart monitoring apps with the upcoming Apple Watch 4 is causing quite a stir in the wearable device market. Last week, Cupertino, CA-based Apple revealed it received nods from FDA for its wearable watch to include an ECG app, that...

Reduced Cost, Higher Speed and Improved Usability with FOBA MarkUS Laser Marking Software Update
With the launch of its latest laser marking software version, MarkUS 2.12, FOBA introduces not only a range of advancements in vision-based laser marking, but also a great potential for cost-savings in direct part marking. The update’s major enhancemen...

AirXpanders Is Pumped for Anticipated Growth After Recent Financing
The company responsible for the first major change in breast tissue expansion in almost 40 years is getting strong support from investors.San Jose, CA-based AirXpanders recently closed a rights offering in Australia to raise roughly A$15.7 million, alo...

AngioDynamics Acquires RadiaDyne for an Undisclosed Sum
It continues to be a busy week for M&A in the medtech industry. This time around AngioDynamics is making a play to acquire RadiaDyne, the developer of a radiation dose monitoring platform, for an undisclosed sum. The deal is set to close at the end of ...

Apple Gains FDA Clearance for ECG App for Apple Watch Series 4
Apple Watch Series 4 will feature two new medical apps marketed with FDA’s blessing, thanks to De Novo classifications. The new watch will offer an ECG app, a software-only mobile medical application that can classify whether there are signs of atrial ...

Highly Qualified 15 & 30 Watt Power Supplies with Size Reduction & Extended Temperature Ranges
Four mechanical styles      Open-Frame with JST Connectors     Open-Frame with PCB Mount Pins     Encapsulated with JST Connectors     Encapsulated with PCB Mount Connections<100uA Lea...

Hologic Heard FDA's Vaginal Rejuvenation Warning Loud and Clear
FDA recently began cracking down on manufacturers of laser and energy-based devices that, in some cases, have been inappropriately marketed for vaginal rejuvenation procedures. In July the agency sent "it has come to our attention" letters to several m...

Supplier Stories for the Week of September 9

An Epic Approach Toward Liquid Biopsy
The liquid biopsy space continues to attract investors and bring in financings that are typically above the average amount medtech firms are able to raise. Epic Sciences is the latest liquid biopsy company to obtain funding and has raised about $52 mil...

Guardant Exposed to Cybersecurity Threat from Phishing Scheme
Liquid Biopsy specialist, Guardant Health faced a cybersecurity attack about two months ago, according to an SEC filing for the firm’s initial public offering. The Redwood City, CA-based company said that private information from about 1,100 individual...

J&J Takes Break from Divestitures and Hops on M&A Trail
Apparently two things happen in September: Football season comes back in full swing, and medtech acquisitions begin to pick up. For the third time this week, a new medtech deal has been announced from a larger player in the game.This time out, Johnson ...

Modernizing the Medtech Supply Chain
Medical devices move from manufacturer to healthcare practitioner through a complex supply chain that is in serious need of total, end-to-end modernization to improve efficiency, accuracy, patient safety, and cost savings. Data exchange between trading...

No, a Wellness Device Can’t Save Your Life (not Directly, Anyway)
It’s no surprise that a large number of wellness devices are being developed to allow today’s tech-savvy patient-consumers to take charge of their own health. Wellness devices are a great way to empower people by giving them access to data. However, it...

Stryker Goes after Another from Most Attractive M&A List
Now it could just be a coincidence, but it seems like Stryker is going after firms that made the list of the Top 25 Most Attractive Medtech Companies on the M&A Radar.In late August the Kalamazoo, MI-based firm revealed it would acquire K2M, a company ...

Supreme Screw Products plans $4.7M expansion, hiring
Supreme Screw Products Inc., a manufacturer of precision-machined components, plans a $4.7 million expansion adjacent to its Plainview headquarters and will hire 20 more workers.

Viveve Sets Its Sights on SUI Indication Target
Viveve Medical has its eyes set on getting approval for a device to treat stress urinary incontinence (SUI). The Englewood, CO-based company has submitted an IDE application into FDA to get authorization to begin the LIBERATE-U.S. clinical trial.LIBERA...

Who Is the Inventor? The Art of Determining Conception of an Idea
In the world of academia and research, scientists spend countless hours thinking, researching, experimenting, and finally, drafting manuscripts before sending them off to journal editors and reviewers. In the course of preparing each article, they may ...

BTG Intensifies Focus on Pulmonary Embolism Through Acquisition
BTG is busy on the M&A trail today. The London-based company has acquired Novate Medical, a firm focused on the prevention of pulmonary embolism (PE) in patients at high risk of venous thromboembolic events, for $20 million in cash with an additional $...

Take Device Performance to the Next Level
When it comes to the world of medical device design, there is always a concern about how different technologies will perform under various environmental conditions. Will your wearable device perform well in high temperatures? Will your latest implantab...

Biotronik Enters into Distribution Agreement with InfoBionics
Biotronik has become the exclusive US distributor for InfoBionic's MoMe Kardia external cardiac diagnostic monitor.The device benefits patients suspected of experiencing cardiac arrhythmias.“When we’re looking at partners - we’re asking ourselves - are...

Boston Scientific's Aggressive M&A Strategy Continues with Augmenix Deal
Tuck-in acquisitions continue to play a key role in Boston Scientific's strategy this year, as evidenced by the company's latest deal, which also happens to be its largest so far in 2018. The Marlborough, MA-based company has agreed to pay $500 million...

Creating the Best Design Plan for Your Device
Every medical device on the market once began as a simple idea crafted to solve a problem. Despite the best intentions of every device developer, many of these ideas fail to reach their potential given the challenging road from original concept to deli...

Livongo and Abbott Take Diabetes Management to New Heights
Digital Health specialist, Livongo Health has found a partner that will help it take an in depth look at the total needs of diabetes patients. The Mountain View, CA-based company is working with Abbott Laboratories to use the Freestyle Libre Pro System...

The Medical Device Excise Tax: Three Potential Outcomes
The battle to repeal the medical device excise tax (MDET) has been a significant focus of the medical device community since the Affordable Care Act (ACA) was enacted on March 23, 2010. At that time, Congress included a 2.3% excise tax on medical devic...

Gore Enhances Structural Heart Portfolio with Pipeline Deal
W. L. Gore & Associates is piping some money into a company that has been stealthily developing an entirely catheter-based repair procedure for patients with mitral valve disease. Flagstaff, AZ-based Gore has acquired Santa Rosa, CA-based Pipeline Medi...

High Elongation, Two Component Epoxy System with Excellent Thermal Shock Resistance

Medtronic Is an Example of Why Diversity Matters
Diversity does matter to medtech (we hope), but a recently published list suggests that some companies are doing a better job than others of making diversity and inclusion more than just a box-ticking exercise. In the medical device and diagnostics ind...

PathMaker Neurosystems Launches European Clinical Trial
PathMaker Neurosystems, a clinical stage company in the bioelectronic medicine space, is seeking to change the treatment paradigm of patients suffering from spasticity secondary to stroke with the MyoRegulator device.The company, which has a presence i...

Supplier Stories for the Week of September 2

Ellipse Buy Reheats M&A Activity for Aesthetics Market
Syneron Candela is slated to acquire Ellipse, a medtech firm that develops Intense Pulse Light and laser-based platforms for a wide variety of medical and aesthetic skin treatments. Terms of the deal were not disclosed.Ellipse's key products include No...

Theranos is Reportedly Shutting Down for Good
Scandal-ridden Theranos is closing up shop, according to a report from the Wall Street Journal.WSJ published an email from Theranos’ CEO David Taylor to shareholders, that said the company will dissolve after it attempts to pay creditors with its remai...

Will Tracker-Like Aesthetics Lead to Anti-Nausea Device Bonanza?
A Canadian-Chinese medical device manufacturer is poised to enter a niche market for nausea-fighting neurostimulation with a sleek wrist-worn transcutaneous electric nerve stimulation (TENS) device, providing an alternative to a long-established manufa...

10x Genomics Seeks to Take Larger Piece of Genomics Market
With the genomics market slated to be worth $24 billion in the next five years, 10x Genomics is moving forward with plans to boost its offerings in the space. The Pleasanton, CA-based firm said it is acquiring Epinomics, a specialist in the growing epi...

A Rival to the Renal Denervation Therapy Procedure?
Vascular Dynamics is taking a different approach in its bid to treat patients with drug-resistant hypertension. While firms like Medtronic have gravitated toward using renal denervation to treat drug- resistant hypertension, Vascular Dynamics is develo...

Attune’s Oversubscribed Round Shows It Resonates with Investors
Attune Medical is really hitting it off with investors. The Chicago-based company, which was once known as Advanced Cooling Therapy, said it has raised about $15.5 million in an over-subscribed series C round.“This last close of the Series C really occ...

Nonradioactive Breast Cancer Marking Platform Gains Second Nod from FDA
Most breast cancer patients have some type of surgery to take out their tumors. But that is not sufficient to ensure that all cancer cells are found and removed. “Cancer cells primarily use the lymphatic system to spread throughout the body and are mos...

Qosina Launches Interactive 3D CAD Model Catalog
Qosina is pleased to release its new interactive catalog of 3D CAD models. This catalog allows customers to instantly download configurable 3D component drawings directly from Qosina’s website.

Qosina Now Carries Unique TPE-Coated-Stem Check Valves
Qosina has added two new patented in-line check valves (#80198 and #80199) to its product line.

Leak Testing - Is Near Enough Good Enough?
Joe Pustka offers sage advice on the importance of regular calibration for your leak tester with examples of why and when calibration is needed. Uson's calibration lab and experienced service technicians can provide you with all the help you need to ma...

A Few Things SaMD Developers Should Know
In today’s digital and connected society, clinicians and patients alike are beginning to expect the same capabilities in medicine. There’s tremendous opportunity for healthcare innovation and transformation through software—but as a developer, do you k...

Biodesix Makes the Case for VeriStrat Through New Study
The Biodesix VeriStrat test received an extra dose of validation last week through a 1,048-patient study published in the Oncologist. The study demonstrated the prognostic value of the VeriStrat test in patients with non-small cell lung cancer (NSCLC)....

How a Design Tweak Triggered a CPAP-Related Product Recall
Sometimes even the most simple design changes can create a safety issue. That seems to be the takeaway from a Class I recall that one manufacturer of a continuous positive airway pressure (CPAP) mask is dealing with.Want to learn how to employ evolutio...

8 Ways EHR Technology Can Improve Diagnosis

Avinger Seeks Nod for Small Vessel Version of Pantheris
Avinger is pursuing a number of different indications to effectively position its Pantheris lumivascular atherectomy system to treat peripheral arterial disease (PAD) in a variety of different patients.The Redwood City, CA-based company’s latest news o...

Stryker to Pick up K2M for $1.4B
Stryker has thrown in its bid to acquire one of the 25 most attractive medtech companies on the M&A radar. The Kalamazoo, MI-based company said it was acquiring K2M, a specialist in complex spine and minimally invasive, in a transaction $1.4 billion.Sp...

Supplier Stories for the Week of August 26

The Line Between Drugs and Devices Continues to Blur
Otsuka America Pharmaceutical has signed a collaboration agreement with Magellan Health designed to facilitate access to the first drug-device combination product approved by FDA to track drug ingestion. The agreement creates an opportunity for doctors...

Alcon Pulls CyPass Micro-Stent from Market Based on Long-Term Safety
One company's loss is another company's gain today in the increasingly competitive microinvasive glaucoma surgical (MIGS) market. Alcon, a division of Novartis, said it is voluntarily removing all versions of the Cypass Micro-Stent from the global mark...

FDA Addresses Severe Lack of Pediatric Devices
To address the scarcity of medical devices that are designed specifically for the pediatric population, FDA convened a public meeting and workshop August 13–14, 2018 to delve into the financial, regulatory, and design constraints associated with this c...

Investors' Faith in Outset Overwhelming with Whopping $132M round
When Leslie Trigg took the helm of Outset Medical in 2013, she helped lead a $60 million series B round. The San Jose-based company was also working to get the Tablo Hemodialysis system, a device that simplifies dialysis procedures, on the market.But o...

ISO 80369: Frequently Asked Questions, Answered
In the years since ISO 80369 was announced, the impact of the changes to the medical device industry have begun to sink in, and momentum has been steadily building as designers are adopting the changes. At DDL, we have observed a dramatic shift away fr...

AtriCure Makes Significant Progress with Afib Therapy
AtriCure is one step closer to getting its Convergent atrial fibrillation (Afib) treatment approach a nod from FDA. The Mason, OH-based company said it has fully completed enrollment of the full cohort of 153 patients in the CONVERGE IDE clinical trial...

Can a New Radiopharmaceutical Company Unlock the Power of PET?
Since its invention and development in the 1970s, positron emission tomography (PET) has made an undeniable impact on cancer, neurology, and cardiology diagnosis. But the full potential of PET has been limited, primarily by cost and because the imaging...

Protecting and Enforcing the Intellectual Property Behind Medical Diagnostics
Medical diagnostic devices detect and measure biological events and structures in the human body. This specific class of medical device derives value from the prevention, diagnosis, monitoring, treatment, and alleviation of human disease and other cond...

Taking a Deeper Look at Device Certification and Recertification
The new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) approved by the European Union in May 2017 tightens requirements in an effort to create a more transparent and uniform process for certifying new medical and IVD devices...

Why a Texas Man Wants Boston Scientific to Stop Calling Him
A man in Texas became so fed up after receiving two prerecorded sales calls from Boston Scientific, that he decided to take the Massachusetts company to court. According to the class action complaint, Steven Sandoe is asking for a jury trial to stop Bo...

Could a New Gut Implant Help Curb Obesity?
BAROnova, a venture backed company developing technologies to treat obesity, said it has submitted a premarket approval (PMA) application to FDA for its TransPyloric Shuttle (TPS) device, a non-surgical treatment option for obese patients.The TPS devic...

GW Plastics Wins Vermont Business Growth Award and Workforce Development Grants
State of Vermont, KeyBank, and VT Business Magazine Honor Leading Contract Manufacturer with $80K Grants and Award for Company Growth

Wright Medical Dishes out $435M for Cartiva
Wright Medical Group said it has reached an agreement to acquire Alpharetta, GA-based Cartiva for $435 million and the deal is expected to close in 4Q18.Cartiva is known for its Synthetic Cartilage Implant (SCI) and won FDA approval for the product in...

Zimmer Biomet's Latest Setback: an FDA Warning Letter
FDA sent Zimmer Biomet a warning letter in connection with the agency's April inspection of the company's Warsaw North campus. The company's quality control problems first cropped up in December 2016 when FDA sent the company a rather long Form 483.  T...

6 Questions to Ask Yourself about ISO 11607 Compliance
When working in medical device packaging, you should know that ISO 11607-1 and -2 are the recognized guidelines for validating terminally sterilized medical device packaging. The ISO 11607 standards are FDA-recognized consensus standards and European n...

Bringing Digital Chemistry into Clinical Laboratories
Ortho Clinical Diagnostics, a global leader in diagnostic platforms and technologies, recently announced that its new digital chemistry system known as the VITROS XT 7600 has received the CE mark ahead of its launch overseas. The new technology combine...

Gore Wins 3 Nods for Molding and Occlusion Balloon
W.L. Gore & Associates has won approvals and clearances from a wide variety of regulatory bodies for its Molding and Occlusion Balloon. The technology has received FDA clearance; a CE mark; and approval from the Japanese Ministry of Health, Labour, and...

Here's What MD+DI Readers Said About The Bleeding Edge
As part of MD+DI's coverage last week of the Netflix documentary, The Bleeding Edge, we asked readers for feedback on the film and its assessment of the medical device industry. A total of 62 respondents took the three-question survey. 1. The Bleeding ...

Immersive Technologies in Medical Device Development: Today and Tomorrow
Medical device designers have a new research tool in their arsenal that facilitates faster immersion for the development team and provides a communication platform to bring patients and healthcare professionals into the development process. Even with t...

Supplier Stories for the Week of August 19

Tapping into the World of Gaming to Fight Opioid Addiction
What does World of Warcraft, Candy Crush Saga, and Angry Birds all have in common? They're all highly-addictive games developed by people who really understand how to keep people engaged with their products. So it makes perfect sense that a life scienc...

Endologix Just Took Out a Hefty Loan
Endologix has taken out a $210.5 million convertible loan facility and issued three warrants for purchase, the struggling endovascular device maker disclosed on a recent SEC filing.Other details, such as how the company plans to use the proceeds, were ...

NeuroMetrix Scoops up $3.8M Milestone Payment from GSK
A partnership with GlaxoSmithKline (GSK) Consumer Healthcare seems to be paying off for pain treatment specialist, NeuroMetrix. The Waltham, MA-based company said it is receiving $3.8 million from GSK because it has achieved a second development milest...

New Hip Replacement Procedure Launches
The first two total hip replacement surgeries using a new 3D technology were recently performed by Gregory Martin, MD, founder of Personalized Orthopedics of the Palm Beaches, at JFK Medical Center, Atlantis, FL. The Conformis Hip System includes speci...

SPR Therapeutics Wins Nod for Dual Lead PNS System
The use of neurostimulation could be an effective weapon in the long fight to eliminate the opioid epidemic in the U.S.FDA just recently signed off on a neurostimulation pain treatment therapy from SPR Therapeutics. The Cleveland-based company said it ...

Which of These Medtech Companies Are on the Prowl for M&A?
business-world-541431__480.jpg Type Image Caption As any medtech CEO can tell you, one thing analysts and investors always want to know is how much of an appetite the company has f...

A Temporary Fix for the EpiPen Crisis?
The ongoing saga of the EpiPen shortage crisis took a new turn today as FDA made a move to extend the expiration dates of certain lots of the allergy drug-device combo by four months.The recent EpiPen shortage has caused FDA to extend the expiration da...

An Australian Startup's Unique Approach to Imaging Lung Function
Here's a story about how a technology developed to study air displacement from jet engines inspired one mechanical engineer to develop a unique solution for medical imaging."I used to work on as a mechanical engineer testing aircraft and other vehicles...

Compact controller communicates via EtherCAT
The EPOS4 Compact positioning controllers from maxon are ready for effortless, industrial Ethernet connectivity. The devices from the successful EPOS4 Compact series can now also be incorporated into EtherCAT networks, thereby creating new opportu...

Medtronic CEO: Our Pipeline Has Never Been Stronger
Medtronic executives were upbeat about the company's fiscal first-quarter 2019 results Monday, and for good reason. The company beat analyst expectations on both earnings and revenue and offered a positive outlook for the back half of the year."We are ...

Renovia Brings in $42.3M for Its Series B Round
Boston-based Renovia has just brought in a rather sizeable financing. The company has raised about $42.3 million in a series B round.The financing will accelerate clinical research, development and new digital therapeutic device launches that are focus...

Trelleborg Acquires Manufacturer of Silicone Components for Healthcare & Medical Industry
Trelleborg signs agreement to acquire Sil-Pro LLC

BrainsWay’s New Indication Is Aimed at OCD Patients
About 3% of the U.S. population suffers from obsessive compulsive disorder (OCD), according to an article published on HealthyPlace.com Statistics also show that one in every 200 children suffers from the disorder.BrainsWay is looking to use its techno...

FDA Medical Device Safety Action Plan: Good or Bad for Medtech?
In April, FDA released a five-pronged Medical Devices Safety Action Plan, full of rhetoric aimed at convincing the public that this new plan will enhance the agency's commitment to patient safety and recognition that safety and innovation should go han...

7 of Bleeding Edge's Most Powerful Moments

Building a Better Insulin Infusion System
Capillary Biomedical is looking to develop a safer more reliable and accurate insulin infusion device. The Irvine, CA-based company has closed on $2.9 million in a seed financing to help get its SteadiSet infusion set on the market.The series seed fina...

Nelson Labs Launches New Global Website to Improve Med Tech & Pharma Customer Experience
New site combines North America and Europe testing capabilities to make it easier to partner with Nelson Labs across its global laboratory network.

The Evolution of Medical Device Regulation in the US
For a deeper dive into the history of medical device regulation in the United States, the following articles from the MD+DI archives may be of interest:FDA and the Device Industry: A Tale of SuspicionThe Development of the Medical Device AmendmentsFDA ...

AssurX Receives HIPAA and HITECH Compliance Type 1 Attestation
AssurX, Inc., a leading provider of enterprise quality management and regulatory compliance software, announced the recent completion of its Type 1 Attestation (AT-C 105 and AT-C 201) for compliance with the Health Insurance Portability & Accountabilit...

Selfie Medicine Is a Thing, But Should It Be?
At a time when taking and sharing selfie photos and videos have become commonplace, it's no surprise that someone would come up with the idea of "selfie medicine."Selfie medicine requires using a mobile app to record a video of themselves taking prescr...

The Bleeding Edge: The Making of a Medical Device Documentary
It's the film that has rattled the medical device industry and left countless viewers speechless. Yes, we're talking about The Bleeding Edge.In the documentary, director Kirby Dick and producer Amy Ziering take a critical look at the device industry, e...

Device Safety and Regulations Questioned in The Bleeding Edge
Netflix’s movie, The Bleeding Edge, is about allegedly unsafe medical devices, how they got to market, and how difficult it is to get them off the market. Living in New York, I actually saw it in a movie theater. It has also received a modest amount of...

Getting the Most Out of Your Design Review
Design reviews are a critical part of the product development process. Many organizations unknowingly falter when it comes to preparing for design reviews. The good news is, there are easy steps organizations can take to ensure that a design review pro...

Is IBM Really Making Progress with Watson in Healthcare?
Recent media reports have cast doubt on the benefits of IBM's Watson computing system in healthcare, but the company isn't taking the criticism lying down."I feel it is imperative to set the record straight," John Kelly III, senior vice president of co...

modum’s Monitoring System Using Sensirion’s Temperature Sensor STS3x
modum.io AG has developed a compact data logger for temperature-controlled shipments that features Sensirion’s STS3x high-accuracy, calibrated digital temperature sensor. As part of the monitoring solution for enabling EU GDP (Good Distribution Practic...

NanoMedical Tackles Opioid Abuse with Combination Device
NanoMedical Systems has received a nearly $3 million grant from the Department of Defense to develop a combination device for the long-term treatment of opioid use.The grant provides $2,993,398 over three years to support formulation development, devic...

New KNF Liquid Pump Platform – Great Price/Performance Ratio
KNF introduces two OEM diaphragm pumps, FF 12 and FF 20, to aspirate, transfer, or pressurize liquids and liquid/gas mixtures. The two models form the basis of a modular platform that allows countless customer-specific modifications. Depending on the m...

Supplier Stories for the Week of August 12

The NPK 03 gas pump from KNF – High pressure performance in a compact size.
The latest KNF micro swing piston gas pump NPK 03 generates high operating pressure with low noise and minimal vibration.

Vaginal Rejuvenation Manufacturers Land in Hot Water with FDA
 Back in February, MD+DI got the low down from an obstetrics and gynecologist specialist in Lubbock, TX on a new vaginal rejuvenation device that her patients have been raving about.  Now it seems the manufacturer of that particular device, along with ...

Creating New Compounds For 3D Printed Medical Devices
A new biomaterial company,  FibreTuff, has announced plans to begin manufacturing cellulose-based biomaterials that are biocompatible, absorbable, and nondegradable for Class I and II medical devices. The company’s PAPC ingredients can be compounded in...

Declining Sales Prompts Endologix to Hit the Strategic Reset Button
John Onopchenko has had his work cut out for him since being promoted to CEO of Endologix in May.The company's revenue dropped 6.1% in the fiscal year 2017 compared to the fiscal year 2016 after a manufacturing glitch interrupted sales of its top-selli...

GID Gets 2nd Lease on Life with New Trial
GI Dynamics has won a nod from FDA to begin a pivotal trial of the embattled EndoBarrier, a technology used to treat patients with type 2 diabetes. The pivotal trial could be a significant turning point in the life of the Lexington, MA-based company, w...

Ivantis Now Has Its MIGS Stent Approved
The competition in the microinvasive glaucoma surgical (MIGS) space is certainly heating up after today’s news. FDA has given a nod to Ivantis’ Hydrus Microstent, which will undoubtedly compete against Glaukos’ iStent.Irvine,CA-based Ivantis’ approval ...

What Should You Expect with Enforcement of the False Claims Act?
Gibson Dunn’s 2018 Mid-Year False Claims Act Update includes several notable developments of interest to medical device manufacturers. In addition to covering recent enforcement activity, the update explains this year’s memorandum from then-Associate A...

6 AI Companies Set to Rock the Medtech World

Thermex-Thermatron Touts ThermaLab
ThermaLab is a fully dedicated area on the Thermex-Thermatron manufacturing floor, filled with multiple equipment types used in the Microwave and RF disciplines

Using the Natural Birth Control Method? There's an App for That!
Image credit: NaturalCycles Nordic ABA mobile app developer just became the first to score FDA permission to market its product as a method of contraception to prevent pregnancy. The app, called Natural Cycles, contains an algorithm that calculates the...

In Vivo Sensors: More than a Space-Age Fantasy?
Why don’t we have in vivo sensors sprinkled around our bodies? How long until we stop investing in temporary ex vivo sensors and start investing in permanent in vivo ones? What technological barriers are in the way? Where would they go for maximum usef...

Precise Laser Mark Positioning even without Product Fixtures
At the IMTS in Chicago FOBA will showcase its innovative marking feature MOSAIC, a significant improvement in automated mark alignment, for the first time in the US. A reliable vision-based laser marking process is now even feasible when products are p...

Supplier Stories for the Week of August 5

Will the Extravascular Method be a Game Changer for ICD Therapy?
Medtronic is aiming for a slightly different approach for implantable defibrillator therapy. Instead of using a transvenous approach the firm is looking at an extravascular method for ICD therapy. On Thursday, the Dublin-based company said it was begin...

Another Day, Another Boston Sci Acquisition
Boston Scientific is proving itself to have more stamina than the Energizer Bunny when it comes to making acquisitions. The Marlborough, MA-based company is now picking up Veniti, a firm that has developed a stent system for treating venous obstructive...

Big Strides in Miniaturization
MD+DI has been tracking miniaturization for some time, as we’ve seen trends deepen in minimally invasive surgeries, wearable devices, advanced drug delivery, and more.Lindsay Mann, director of marketing for MTD Micro Molding, tells MD+DI that about 25%...

Boston Scientific's Lotus Valve Could Get FDA Approval in Mid-2019
Boston Scientific is on a roll today. Not only has the company announced yet another acquisition, but it also said it plans to submit the final technical module of the Lotus Edge aortic valve system premarket approval (PMA) application to FDA next week...

Could a New Imaging Device Curb Thyroid Cancer?
A new development out of Taiwan could improve thyroid cancer screening after doctors unveiled a new diagnostic imaging tool last month. The AmCAD-UT Detection technology developed by AmCad BioMed Corp. is being hailed as the world’s first ultrasound CA...

Medical Guardian Designs Smartwatch for Aging Population
The International Data Corporation is saying that worldwide shipments of wearable devices are on track to grow 15.1% this year totaling more than 132.9 million units. The concept of wearables is gaining traction especially in healthcare.Medical Guardia...

New Thinking Informs Soft-Material 3D Printing
As 3D printing evolves, researchers have gone beyond mere fabrication processes to developing techniques for optimizing how particular materials can be printed. To that end, researchers at Carnegie Mellon University’s College of Engineering have develo...

Putting Fat Cells to Use in Orthopedics
Arthroscopic knee surgery for degenerative knee disease is a common orthopedic procedure, reportedly performed more than two million times a year globally. And these are just the statistics for knee procedures. The shoulder, hip, wrist, elbow, and ankl...

Sotera Health’s Nelson Labs announces acquisition of New Jersey-based Gibraltar Laboratories
Acquisition strengthens Nelson Labs’ outsourced testing capabilities to better serve the pharmaceutical and medical device industries

This Medtech Company Is Rocking Cleveland with New Hires
Cleveland does indeed seem to "rock", at least for one medtech company that has set up shop in the city. Goleta, CA-based Inogen, which makes portable oxygen concentrators (POCs) is planning to grow its presence in Cleveland. CEO Scott Wilkinson said t...

Could Ozone Emerge as Sterilization Method of Choice for Advanced Medtech?
Anacail Ltd., a start-up spun out of the University of Glasgow, is developing a new approach to sterilizing medical devices using ozone. The company reported that it has been awarded a grant through Innovate UK to develop a high-throughput, scalable, a...

How EchoNous Turned the Nursing Stand into an AI Station
With the goal of reinventing what has historically been an afterthought medical device element, EchoNous commissioned an iconic industrial designer and solicited advice from clinicians and biomedical leaders at one of the nation's top health systems to...

Oliver Healthcare Packaging Strengthens Presence in Asia To Support Growing Customer Base
Oliver Expands Team and Opens New Office in Singapore

Pfizer Is Keeping Details of New 'Rescue Pen' Low Key, for Now
Antares Pharma has agreed to help Pfizer develop a combination drug-device rescue pen using Antares' QuickShot auto injector.The companies have not yet disclosed what drug the device will deliver, but Antares CEO Bob Apple shared a few details about th...

Viveve Developing Device to Improve Sexual Function in Women
Viveve Medical has received a nod from FDA to continue enrollment in a clinical trial to evaluate a technology to improve sexual function in women following vaginal childbirth. The Viveve Treatment of the Vaginal Introitus to EValuate Safety and Effica...

Boston Scientific to Layoff 85 Massachusetts Workers by Year End
Boston Scientific, which has been making acquisitions left and right this year, plans to lay off 85 workers at a Burlington, MA-based facility that came with the company's acquisition of Cosman Medical in 2016.Cosman developed radiofrequency ablation t...

General Data Protection Regulation: What Does It All Mean?
Every day more and more electronic devices are “connected” and medical devices are no exception. Medical devices are connected to network servers for many end outcomes including, preventative diagnostics, patient-care management, medication adherence, ...

High Tensile Strength Epoxy Adhesive Utilizes Renewable Biomaterial

LivaNova Looking to Be a Standout Firm in TMVR
LivaNova is getting closer to becoming a major player in the transcatheter mitral valve replacement (TMVR) space. The company, which was formed when Sorin Group and Cyberonics merged back in 2015, said it has concluded, PRELUDE, the U.S. feasibility st...

Scout Marks the Spot in Soft Tissue for Cancer Treatment
Cianna Medical celebrated another regulatory milestone this week after FDA cleared its Scout reflector for an extended indication, allowing the tiny device to be used to mark soft tissue sites, including lymph nodes. The non-radioactive wire-free local...

JenaValve Getting Closer to its U.S. TAVR Goal
JenaValve Technology is continuing to make progress in bringing its transcatheter aortic valve replacement (TAVR) system to the U.S. market. The Irvine, CA-based company has initiated patient enrollment in an early feasibility study (EFS) of its next g...

Pentax Bets on PlasmaBiotics in the Fight Against Scope-Related Infections
Pentax Medical, a division of the Hoya Group, acquired a controlling interest in PlasmaBiotics this week, an investment that is expected to strengthen Pentax's hygiene portfolio and help it reduce cross-contamination risks associated with endoscopy dev...

Roche is on the “SurePath” for Cervical Cancer Screening with Approval
Roche has won a monumental approval from FDA that stands to enhance its cervical cancer detection offerings. The Basel, Switzerland-based company has received a nod for its cobas Human Papillomavirus (HPV) Test as a first-line screening test for cervic...

Stryker Touts 3D-Printed Tritanium Cages for Spinal Fusion
A recently published pre-clinical animal study highlights the expanding role that 3D printing is playing in medicine, particularly in orthopedics.The study, published in the July issue of The Spine Journal demonstrated that Stryker's 3D-printed Tritani...

MDxHealth’s Liquid Biopsy Test Proven to Be Cost-Effective
A new study shows the cost-effectiveness of MDxHealth’s prostate cancer test. The Irvine, CA-based company’s SelectMDx is a liquid biopsy test that helps predict the likelihood that clinically significant prostate cancer will be found by a biopsy.The M...

Pricing Headwinds Make Mazor-Medtronic Pact a Double-Edge Sword
You have to give some to get some, as the saying goes, and that certainly appears to be Mazor Robotics' attitude toward its partnership with Medtronic.The smaller robotics company's revenue slipped 14% to $13.2 million during the second quarter, compar...

Supplier Stories for the Week of July 29

V-Go Shown to Have Improved Benefit for Insulin Patients
There is clinical benefit from using Valeritas Holdings’ V-Go Wearable Insulin Delivery Device. The Bridgewater, NJ-based company unveiled results from a poster titled “Use of V-Go Wearable Insulin Delivery device by Advanced Practitioners Demonstrated...

Could Faxitron Really Be the Perfect Tuck-in for Hologic?
In a move to broaden and further strengthen its breast health portfolio, Hologic said it has acquired digital specialist Faxitron Bioptics for $85 million.Tucson, AZ-based Faxitron markets a broad portfolio of products across major categories including...

DexCom Surpassed Analyst Expectations in the Second Quarter
Diabetes patients are clamoring to get their hands on DexCom's newest gadget, the G6 continuous glucose monitoring (CGM) system.FDA approved the device in March and the company decided to get the product into customer's hands as soon as possible, even ...

ElectroCore Is Changing the Game in Bioelectronics
electroCore, a player in the bioelectronic’s market is on a mission to redefine the way patients are treated for migraines. The Basking Ridge, N.J.-based company recently launched the gammaCore Sapphire, a second-generation device that is non-invasive ...

Qosina Unveils a New Line of Tyvek® Sterilization Supplies
Qosina has introduced a line of Tyvek® sterilization supplies for biopharmaceutical equipment and medical device components. Qosina's off-the-shelf Tyvek® sterilization supplies include a large assortment of pouches, sheets and tubes, which are availab...

Sprint^mD Demonstrates Innovation
Uson has launched a new leak tester designed to help medical device manufactures for the challenge of test small but sometimes complex parts. Joe Pustka, Uson's director of applications engineering discusses features of the new product and the role of ...

Will Investors Rescue Brazos' Migraine Management Device?
A startup company trying to develop a new wearable migraine management therapy device is realizing that getting a new medical device to market can be a financial headache, pardon the pun.Southlake, TX-based Brazos Biomedical, an operating unit of Ameri...

Are Bioresorbable Stents Destined for a Comeback?
The excitement around bioresorbable stents might have calmed down considerably over the last year, but all that could change. Reva Medical, a San Diego, CA-based company is bringing the technology back into the spotlight with a recent approval. The com...

How Alexa Is Changing Healthcare

Medtronic Fires up SynchroMed II System for New Collaboration
Medtronic is partnering with United Therapeutics to launch a therapy that could help treat patients with pulmonary arterial hypertension (PAH). The Dublin-based company said it has received FDA approval for the Implantable System for Remodulin (ISR).In...

SCHOTT Acquires Primoceler to Advance Next-Gen Implantable Devices
Implantable devices are advancing at some pretty impressive rates, as devices are quickly becoming more intelligent and versatile. These days implantable devices are designed to not only serve a medical need, but also capture and transmit data in real ...

Abbott Wins Nod for 14 Day Version of Freestyle Libre
Abbott Laboratories has received FDA approval of the Freestyle Libre 14 Day Flash Glucose Monitoring System (CGM). FDA’s nod of the Abbott, IL-based company’s device follows on the heels of the 2017 approval of the 10 Day Freestyle Libre CGM in the U.S...

Could New Smart Glasses Make Surgery Safer and More Efficient?
Last week a group of physicians and researchers from Taiwan Main Orthopedics Co. unveiled what could be one of the most exciting medical device technologies of the summer—a new type of smart surgical glasses that could give surgeons the ability to see ...

Raumedic hires its 800th employee
Raumedic has its sights set on growth. In July, the company’s 800th employee signed an employment contract at the medical technology company. Thomas Schlesier will start working at the company’s headquarters in Helmbrechts, Germany, as an application e...

Zoll Wins $5.4M in Contract Dispute with AutoMedx
Zoll Medical said it was awarded about $1.8 million in damages plus $3.6 million in attorneys’ fees, costs, an interest for what it claims was a breach of contract by AutoMedx. The Chelmsford, MA -based company added that the arbitrator also denied all...

Bringing Hollywood to Medtech
Typically, the tutorials for medical devices aren’t extremely flashy. The videos convey a simple message and get straight to the point. However, one company is bringing high quality production levels to the medtech industry. Spotburner is a specialist ...

Diabetic Koala at the San Diego Zoo Gets Help from the Latest in CGM
Quincy, a diabetic koala at the San Diego Zoo, is rocking a wearable new technology these days that may make his life—and maybe even other animals lives—much easier. Turns out that humans aren’t the only ones that suffer from diabetes. Many mammals als...

Do You Know How to Manage Japan’s Revised Reimbursement Approach?
One significant change in Japan’s revised reimbursement process for new medical devices involves pricing.Applicants have been required for some time to provide pricing for their medical devices in other primary markets such as the United States, the Un...

Sanofi Ventures Leads Funding Round for Click
Click Therapeutics has received about $17 million in a financing round led by Sanofi Ventures. The NY-based company is a specialist in digital therapeutic solutions such as prescription medical treatments.The company has a commercial product for smokin...

Zimmer Biomet CEO Says Remediation Is Progressing with Urgency
Editor's note: This story has been updated to include statements made during Zimmer Biomet's second-quarter earnings call. A previous version of this story included statements from the company's first-quarter earnings call. MD+DI regrets any confusion ...

Abbott Makes Strong Statement in TMVR Space with SUMMIT
Abbott Laboratories has hit a substantial milestone in its plan to bring the Tendyne transcatheter mitral valve replacement (TMVR) system to the U.S. market. The Abbott Park, IL-based company said it has initiated SUMMIT, a pivotal clinical study of th...

Don't Expect Boston Scientific M&A to Slow Down Anytime Soon
It came as no surprise that M&A seemed to be top of mind for many investors during Boston Scientific's second-quarter earnings call Wednesday. As MD+DI has reported on recently, the company has announced six acquisitions since March, including two in J...

Röchling Continues to Grow in Medical and Industrial Technology
Acquisition of FRANK plastic AG, headquartered in Baden-Württemberg Ideal complement to the product portfolio and production technologies Location in the northern Black Forest reinforces the Röchling medical network

Supplier Stories for the Week of July 22

Apixio Launches AI Healthcare Audit Solution
Apixio is using artificial intelligence (AI) to make healthcare audits simpler and more efficient for all involved. The San Mateo, CA-based company is launching an AI solution called the HCC Auditor, to help health plans and provider organizations to u...

Bioelectronics: A New era in Medical Care Is on the Horizon
Bioelectronics, generally defined, isn't new. Doctors Rune Elmqvist and Ake Senning implanted the first pacemaker in 1958. FDA approved the first spinal cord stimulator (SCS) in 1989.While both solutions continue to help patients worldwide, smaller, mo...

Nevro Comes Out Ahead in the Latest Legal Round Against Boston Scientific
Nevro Corp.'s shares sold off 26% on Tuesday as investors braced for an adverse ruling in the company's lengthy patent battle with Boston Scientific. Today, the Redwood City, CA-based company's shares rebounded 24% in premarket trading after Nevro repo...

What Could Total Connectivity Mean for Medtech and for Healthcare?
In the very near future, healthcare systems could be able to connect almost all medical devices to their networks. By 2025, most hospitals will have the ability to network connect more than 90% of their devices, predicted David Niewolny, director, mark...

Allurion Puts Consumers First with Weight Loss Balloon Treatment
Allurion Technologies is hoping to be able to get FDA approval to launch its obesity treatment balloon in 2020. The Natick, MA-based company said it was making progress toward its goal of getting Elipse on the U.S market by completing enrollment in the...

An Interview with Martha Shadan
Martha Shadan has done what few other medtech leaders ever dream of doing. After a string of success stories in large medtech companies, she transitioned to the startup world. Most medical device executives who attempt this transition after big medtech...

Analysts Expect Merit Medical's Hot Streak to Last
Terumo's loss appears to be Merit Medical's gain. Product shortages at the former benefitted Merit during the last two weeks of the second quarter by boosting sales across several product lines, including sheath introducers, guidewires, microcatheters,...

Ding Dong the Device Tax Is (Almost) Dead, Again
The House of Representatives took a big step Tuesday toward kicking the 2.3% medical device tax to the curb for good. The tax, which was included in the Affordable Care Act in 2010 has been highly criticized on both sides of the aisle as being bad for ...

FDA Gets Cancer Test on the Fast Track
Personal Genome Diagnostics (PGDx) is making waves in the liquid biopsy space with news of its breakthrough device designation from FDA. The Baltimore, MD-based company said its PGDx elio plasma resolve received the designation.The company said the PGD...

Bioventus Sheds its BMP Business For Undisclosed Sum
Bioventus is divesting its next generation bone morphogenetic protein (BMP) development program to a newly formed by Viscogliosi Brothers LLC for an undisclosed sum. The deal is expected to close in late Q318.When completed, Bioventus will receive an e...

Could DNA Help Doctors Predict Opioid Addiction?
A new partnership between Bentley University and Gravity Diagnostics will allow researchers to begin exploring the genetic links between patients and opioid addiction. The research project aims to help better inform doctors on how likely a patient is t...

3D Printer of PEKK Implants Expanding in Asia
After receiving accreditation as a foreign medical device manufacturer by the Japanese Ministry of Health, Labour, and Welfare, Oxford Performance Materials Inc. (OPM) has forged a partnership to establish manufacturing and marketing in Japan. Known fo...

B. Braun to Pick Up NxStage’s Bloodlines Business
Braun Medical is set to acquire NxStage Medical’s bloodlines business. The potential acquisition is subject to Federal Trade Commission approval and is contingent upon the closing of the $2 billion merger between NxStage and Waltham, MA-based Fresenius...

Bayer Throws in the Towel on Essure Birth Control Implant
Bayer said Friday it will stop selling its Essure birth control system in the United States at the end of the year, citing a decline in U.S. sales of the device and the conclusion that the Essure business is no longer sustainable.Although the controver...

BTG Labs’ Surface Analyst™ Measures to Instantly Evaluate the Surface Condition of Medical Devices
Cincinnati, OH–– The Surface Analyst™ is an innovative handheld solution for measuring how prepared a material surface is for adhesion. Developed and manufactured by BTG Labs, it is a fast, easy, accurate and nondestructive instrument for use by manufa...

Intuitive Set a High Bar for New Entrants in Surgical Robotics
Intuitive Surgical is well aware that the field it has dominated for years is becoming increasingly competitive with new entrants. But CEO Gary Guthart always manages to sound confident during earnings calls and tends to let the numbers speak for thems...

Meril Aims for Emerging Markets with its TAVR Device
Yet another company is throwing its hat into the transcatheter aortic valve replacement system(TAVR) market. However, Meril Lifesciences is going a different route than other established firms in the space and is initially targeting emerging markets. M...

450 Watt 3x5” Power Supply for Medical and Industrial Applications
TRACO POWER announces the release of the TPP 450A series

Investors See Big Opportunity in AI
Artificial Intelligence could be the next big market in medtech that investors flock to. Earlier this week, Viz.ai proved that this might just be the case as it raised about $21 million in a series A round. The round was led by Kleiner Perkins, with pa...

Needle-Free Option for Collecting Blood Adopted
Designed to draw blood from in-dwelling peripheral IV catheters and eliminate the need for multiple needle-sticks, PIVO is being implemented at University Hospitals Cleveland Medical Center for inpatient blood draws. “UH is rolling out PIVO in 20- and ...

Sensirion Presents its Long-Term Stable Particulate Matter Sensor at IoTE 2018
At this year’s IoTE 2018 in Shenzhen (July 31 – August 2) Sensirion, the expert in environmental sensing, is an-nouncing the SPS30 – its long-term stable, high-accuracy particulate matter sensor.

Starrett to Showcase Full Complement of Leading Metrology Solutions at IMTS 2018
Robot-Served New Vision System, New Force Testing Product Line and Electronic Gages to be Highlighted in Booth No. 135532.

Supplier Stories for the Week of July 15

Driving Medical IoT Concepts with Force-Sensitive Resistor Technology
The Internet of Things (IoT) represents a growing wave of change that brings several new challenges to design engineers across all industries and markets. While it is a somewhat nebulous concept, IoT is broadly defined as a network of smart devices tha...

Is Abbott Losing Share in Key Medtech Markets?
By and large, Abbott Laboratories had a phenomenal second quarter this year – and investors took notice. The company's stock hit its highest point since 1995 on Wednesday after beating Wall Street's quarterly expectations and raising its own outlook fo...

Lots of Light in the Biophotonics Tunnel
In a case of ironic coincidence recently, the Tandon School of Engineering at New York University and the U.S. Securities and Exchange Commission issued statements days apart about revolutionary technologies and those who develop them. In the case of t...

Medtronic Pumps Confidence in MiniMed Through Performance Guarantee
Medtronic has been leading the industry in the charge toward value-based care, and its efforts have been paying off in spades, as MD+DI has recently observed. Now, the company has found yet another way to stay ahead of the curve.The company recently la...

Researchers Print Microelectrodes on Gummy Candies for New Medical Applications
Though they are best known as a popular candy, gummy bears have found a different use as a transport for microelectrodes with increased biocompatibility, thanks to researchers from the Technical University of Munich.A team there, collaborating with res...

FDA Hits Baxter with Warning Letter in Connection with Claris Acquisition
A full year after acquiring Claris Injectables, FDA has hit Baxter with a warning letter in connection with the agency’s inspection of the acquired facilities in Ahmedabad, India.Baxter added Claris to the pharmaceuticals side of its business last year...

Judge Refuses to Dismiss Negligence Suit Against Abbott/St. Jude
There's never really a good place to have a medical emergency, but sitting on an airplane is certainly far from ideal, as Kristen Bull knows all too well. Bull was on an airplane on the tarmac at a South Carolina airport in October 2015 when her implan...

NuVasive Launches Next-Gen Reline Spine Fixation System
NuVasive has launched its Reline MAS Midline (RMM), the next evolution of its Reline system designed to provide procedural versatility in a compact midline construct.The San Diego, CA-based company said the RMM incorporates extremely low-profile modula...

Sensirion’s CO2 and RH/T Sensor Module Is Now Available Globally
The SCD30 humidity, temperature and carbon dioxide concentration sensor is now available worldwide through Sensirion’s distribution network.

Out with the Old, in with the ... Newish?
John Onopchenko joined Endologix at a time when the Irvine, CA-based company had just experienced a recall of its AFX2 endograft system in the United States and a temporary suspension of its CE mark for the product in Europe."That reality drove my focu...

Breathing Easier with Single-Use Bronchoscopes
A recent study, funded by 3M Company and supported by Healthmark Industries, found that most of the reusable bronchoscopes it examined, even when cleaned and disinfected using current reprocessing guidelines, remained contaminated or damaged. “The res...

Join the Conversation: Medtech M&A Trends
MD+DI News Editor Amanda Pedersen talks about recent M&A trends in medtech and the attributes that make companies stand out as potential acquisition targets.Here is a link to our recently-published list of the 25 Most Attractive Medtech Companies on th...

Potrero Smartens up Its Catheter to Predict Diseases
Potrero Medical is hoping to use and machine learning to help predict diseases. To help with this goal, the San Francisco, CA-based company has raised $26.6 million in a series C round. The financing was led by China-focused healthcare investment firm ...

Researchers Achieve First 3D Printing of Human Corneas
Researchers in the UK have achieved the first 3D printing of human corneas that can potentially be used in replacement surgeries. In doing so, they have paved the way for an unlimited and easy-to-fabricate supply of new corneas to patients that need th...

Supplier Stories for the Week of July 8

Angiodynamics CEO: We Are Ready for M&A
Angiodynamics ended May with $74.1 million in cash and cash equivalents and is ready to put it to work."As we have discussed in recent quarters, one of our top strategic priorities has been portfolio optimization both internally and through value creat...

Guess What Alphabet’s Verily is Up to Now
Verily Life Sciences has formed yet another joint venture with a medtech company. This time Verily, once known as Google’s life sciences division, is teaming up with sleep-health specialist ResMed to tackle sleep apnea. The collaboration with ResMed ex...

GW Plastics Announces Senior Leadership Team Changes
Announcing the recent promotions of three executive team members.

Medtronic’s HVAD System Just Became Less Invasive
Medtronic has gained FDA approval for a less-invasive implant approach of its HVAD System, a left ventricular assist device (LVAD) for advanced heart failure patients. The Dublin-based company picked up the technology when it acquired HeartWare in 2016...

Taking the Guess Work out of TEE Procedures
A start-up company is hoping to take the guess work out of transesophageal echocardiogram (TEE) procedures. Visura Technologies said it has developed TEE Camera Assist Device (TEECAD) System, a single use disposable camera that easily attaches to a TEE...

Viant Expands Leadership Team
Company Appoints former Medtronic and Integer Executives to Leadership Team Following Integer AS&O Acquisition

What If Nevro Loses Legal Battle to Boston Scientific?
Nevro and Boston Scientific have been clashing over intellectual property since shortly after FDA approved Nevro's Senza spinal cord stimulation (SCS) system in May 2015. Now, Nevro is suffering a massive stock dip prompted by a surprise preliminary ru...

Eversense Buzz Continues with New Collaboration
Two powerhouses in the diabetes treatment and management space are in a new collaboration. Senseonics, which has been buzzing since receiving a PMA for the Eversense continuous glucose monitoring CGM system in June, and Glooko have announced a new agre...

Medtronic's Value-Based Partnerships are Paying Off in Spades
Dublin, Ireland-based Medtronic continues to lead the charge toward value-based care, and it's beginning to pay off in a big way. One of the company's value-based care partners, UnitedHealthcare, has seen a 27% decline in the rate of preventable hospit...

Otsuka Finds Paradise in Renal Denervation Market
Any doubts about medtech’s interest in renal denervation can now be put to rest. Otsuka Holdings is showing its very interested in the space by making a move to acquire ReCor Medical for an undisclosed sum.Tokyo-based Otsuka’s big play comes just a few...

Product Renderings: Why You Shouldn't Overlook Them
Medical device companies face many challenges throughout the product lifecycle—from the complexities of design engineering to the hard work involved in luring investors and marketing the product. As a result, it’s easy for some companies to not give pr...

Biodesix Deal Adds to Active M&A Day for Medtech
Biodesix made a move to expand its lung testing franchise on a day already buzzing with M&A activity. The Boulder, CO-based company said it was acquiring Integrated Diagnostics for an undisclosed sum.The agreement includes the XL2 test, Seattle, WA-bas...

Bovie Medical to Divest Its Core Business Segment
Bovie Medical is turning away from its core business segment and will focus on the commercialization of its J-Plasma/Renuvion Cosmetic Technology. The Clearwater, FL-based company is making this move after it announced it would sell its core business s...

Caplugs Custom Medical Molding
Our custom molding capabilities include six different molding processes.

Medical Approved 15 Watt DC-DC Converter in 1.0 x 1.6" package
Wide 2:1 input voltage 15 W DC/DC converter in a 1.6 x 1 ” plastic case.I/O isolation 5000 VACrms rated for 250 VACrms working voltage.Certification according to IEC/EN/ES 60601-1 3rd edition for 2xMOPP.Risk management process according to ISO 14971 in...

MedPlast Closes Acquisition and Rebrands as Viant
Company Unveils New Name After Acquiring Integer’s Advanced Surgical and Orthopedics Business

Qosina Adds New Closed Male Luer Lock Valves to Its Line
Qosina has added four new closed male luer lock valve connectors to its existing line of luer-activated valves.

Zimmer Biomet Pushes Back on 'Misunderstandings' During Latest FDA Inspection
Zimmer Biomet is still working to address quality control problems at its Warsaw North campus (previously referred to as the legacy Biomet facility) that was hit in December 2016 with an unusually long Form 483. FDA re-inspected the facility in April a...

25 Most Attractive Medtech Companies on the M&A Radar - UPDATED

BASF acquires two manufacturers of 3D-printing materials
BASF New Business GmbH (BNB; Ludwigshafen, Germany) has acquired German and French companies involved with the manufacture of 3D-printing materials in the latest effort to enhance its presence in the fast-growing field of 3D printing. The latest BASF...

Could a Direct-to-Consumer Sensor Improve Adherence?
In March, Adherium received 510(k) clearance from FDA for over-the-counter (OTC) sales of its Smartinhaler sensor for AstraZeneca’s Symbicort aerosol asthma inhaler and is now preparing to sell its sensor-based solution directly to patients. The sensor...

Intuitive Grabs FDA Nod and Makes a Play to Expand Its Presence
Things continue to look up for Intuitive Surgical, a pioneer in the surgical robotics space. The Sunnyvale, CA-based company has received an FDA nod for its SureForm 60mm wristed staple and has purchased property for $1.35 million to expand its presenc...

Artificial Intelligence: The Game Changer of Medtech
The year 2018 has seen a good influx of innovative medical devices. Artificial intelligence (AI) serves as a critical component in most of these novel devices.FDA has defined artificial intelligence as:“A device or a product that can imitate intelligen...

Boston Scientific Continues to Be Relentless with M&A
Boston Scientific is set to acquire Cryterion Medical, a company developing single-shot cryoablation platform for the treatment of atrial fibrillation (AF), for about $202 million in up-front cash. The price is for the 65% remaining stake in the Carlsb...

High Performance Sensorless Control
Compact wiring and slim design

Is This the Turning of the Tide for Renal Denervation?
Renal denervation as a treatment for high blood pressure has become somewhat of a white whale for the medical device industry. After Medtronic's initial attempt at using renal denervation for treatment-resistant hypertension failed back in January 2014...

ivWatch Finds Strong Ally in Philips to Monitor Peripheral IVs
When it comes to peripheral intravenous (IV) therapy, doctors and nurses have come to accept that things might not go smoothly. Nearly 80% of hospital patients in the U.S. receive an IV — a procedure that has a startling 50% fail rate. ivWatch, the onl...

Raumedic Founds Company in France
Raumedic AG has converted its existing branch in Voiron, France, into an independent subsidiary effective July 1. The long-serving Sales Manager Claude Zingg has been appointed as Managing Director of Raumedic S.A.R.L. Apart from being in charge of the...

Supplier Stories for the Week of July 1

A Silver Bullet in Reducing Infections?
Silver is precious not only for its beauty and monetary value, but it may also have significant benefits in fighting off bacterial infections. Although silver is not new in the medical world—Hippocrates described its use in wound care as far back as 40...

AssurX GDPR Compliance: Benefits and Lessons Learned
As a company dedicated to developing solutions for quality management and compliance, AssurX QMS Software approached the extensive scope of GDPR compliance with the expertise to identify, document and remediate any process issues where data privacy is ...

Management Turmoil Adds Salt to an Already Wounded MiMedx
Regenerative medicine company MiMedx appears to be cleaning house in connection with its ongoing internal accounting investigation and federal investigations.Earlier this week the Marietta, GA-based company announced the resignation of CEO Pete Petit, ...

Can Fresca's Sleep Apnea Device 'Curve' the CPAP Compliance Problem?
People who suffer from obstructive sleep apnea (OSA) generally hate wearing their CPAP (continuous positive airway pressure) mask. Many refuse to even give it a try. Even some doctors have a love-hate relationship with this standard sleep apnea therapy...

How a New Emphysema Device Won FDA Approval in Six Months
FDA has approved a new device intended to treat breathing difficulty associated with severe emphysema. The approval comes just two weeks after an FDA advisory panel shot down a competing technology targeting the same patient population.The agency appro...

Nu-Med Files Patent for a Reactive Tube Coating
Nu-Med Plus, a Salt Lake City, UT-based medical device company, recently filed for a patent covering its chemically reactive coating for medical tubing. The company said the technology could help patients receive contaminant-free nitric oxide, which is...

Nuvectra Suffers Painful Stock Drop After Regulatory Update
A company that spun out of Greatbatch in 2016 experienced a painful drop in its stock price Monday after updating investors on its regulatory progress for a sacral neuromodulation (SNM) system designed to treat chronic urinary retention and the symptom...

Leak Testing Training Service
Medical device designers, product managers, production engineers and quality assurance can take advantage of Uson's leak testing training service. For more information contact Uson's Director of Applications Engineering, Joe Pustka [email protected]

Cybersecurity: Are You Prepared?
There are many regulatory challenges facing medical device companies, but nearing the top of the list is data protection. Companies are spending resources and dollars to avoid becoming the next company confronting cyber threats and/or data breaches. Me...

New Partnership Expands Medigus’ Presence to Orthopedics
Medigus is entering bold new territory thanks in part to a manufacturing and development agreement with A.M. Surgical, an orthopedics company. Omer, Israel -based Medigus has primarily been known for its MUSE technology that performs the Transoral Fund...

Novartis and Alcon to Separate
Novartis said it plans to spin out its Alcon Division into a separately-traded company. The move will allow the Basel, Switzerland-based company and Alcon to focus on respective growth strategies. If the split meets general market conditions, regulator...

One Doctor's Hope for Better Patient Monitoring
Editor's Note: Since this story was originally published, Ashish Khanna, MD, who was interviewed for the story, has taken a new position. He is now an associate professor of anesthesiology and intensivist at the Wake Forest School of Medicine.Anyone wh...

10 Medtech Stories That Kept Us on Our Toes in Q2
the-gap-message-2310064__480.jpg Type Image Caption Second Quarter Brings Layoffs, Lawsuits, and Criminal Charges (oh my!)From layoffs and lawsuits to product delays and criminal c...

Are We in Store for More M&A in the Liquid Biopsy Space?
M&A activity in the liquid biopsy space is picking up as Bio-Techne said it will acquire Exosome Diagnostics for $250 million plus $325 million in milestones.Waltham, MA-based Exosome has developed the urine-based test ExoDx Prostate (IntelliScore) to ...

CMS Will Reconsider Its Stance on TAVR
Centers for Medicare & Medicaid Services (CMS) took an unprecedented stance in 2012 when it decided to cover transcatheter aortic valve replacement (TAVR) with strict restrictions regarding its use in patients with symptomatic aortic stenosis.One of th...

Sensile, Sanofi, and Verily Form Diabetes Dream Team
There has been a lot of movement in the diabetes space lately – especially with the 78th Scientific Sessions of the American Diabetes Association ending earlier this week.One of the latest developments in the diabetes space is a “dream team” collaborat...

Better Imaging for Prostate Cancer Patients?
A new study is giving greater in insight on the effectiveness of imaging patients suffering from prostate cancer. Data from the LOCATE trial shows that the addition of fluorine-18-fluciclovine positron emission tomography/computed tomography (PET/CT) t...

Complex Tubing Set Aids Liver Transplants
Raumedic produces a complex tubing set that simulates vital bodily functions for Metra, a new device for liver transplants from the British firm OrganOx. Within the overall system, the disposable set helps to keep donor livers perfused outside of the b...

Ellipsys' FDA Nod Is a Major Turning Point for Hemodialysis
A new catheter-based technology could provide a non-surgical option for arteriovenous (AV) fistula creation. FDA recently gave de novo clearance to Avenu Medical’s Ellipsys Vascular Access System.The San Juan Capistrano, CA-based company’s device chall...

Reinventing the Healthcare Continuum with Machine Data Analytics
As healthcare delivery organizations navigate the dual challenges of providing high-quality medical care while facing tougher cost control measures from insurance carriers and government entities, one strategy they are turning to is optimization of bot...

Dare to 'Dreem': J&J Invests in Sleep-Focused Medtech Startup
A neurotech startup that dared to dream has attracted the attention of a major investor.Johnson & Johnson Development Corp. (JJDC), J&J's investment arm, led a $35 million investment to help San Francisco, CA-based Dreem further develop its headband br...

Do Leadless Pacemakers Really Have Fewer Complications in Patients?
A Cleveland Clinic-led study shows that leadless pacemakers have fewer mid-term and short-term complications than traditional transvenous pacemakers. The study was recently published in Heart Rhythm.“The issue with traditional pacemakers, which have be...

Epoxy Features Very Low Coefficient of Thermal Expansion
Master Bond has developed a new epoxy

GE Healthcare to Stand on Its Own
General Electric is shaking things up a bit by spinning out its healthcare division as a publicly-traded company. The move will allow GE to focus on aviation, power, and renewable energy.GE Healthcare has long been a bright spot for its poor-performing...

New Leak Tester Delivers Reliable, Highly Accurate, Multi-Application Leak Testing that Provides Data and Intelligence to Optimize Manufacturing Processes
Uson’s SprintmD, designed for the medical device industry, offers a wide range of multifunctional testing, a fast cycle time, enhanced security features, and improved data collection, archiving, and reporting, to deliver consistent, high-quality result...

Supplier Stories for the Week of June 24

Using a Brain-Computer Interface to Ease Epilepsy Seizures
Patients suffering from epilepsy may soon have a new device that could help treat seizures by preventing them altogether. NeuroPace Inc., a medical technology company based out of Silicon Valley, announced the launching of its flagship technology earli...

40 to 65W Medical External Power Supplies are Compliant to DoE Level VI and EU Tier 2 v5 Efficiency Standards
40-65W Medical AC-DC External Power Supplies

Beyond the Baggie: High Hopes for Nasal Delivery of Medical Cannabis
What happens when a leading medical cannabis company hooks up with a respiratory device company? Dose-metered, nasally-delivered cannabis-based medicines, according to Columbia Care and Rhinomed. The two companies have inked a licensing agreement for t...

Glaucoma Surgery Space Heats Up with New Approval
Glaukos has received FDA approval to market the iStent inject Trabecular Micro-Bypass System. The nod gives the San Clemente, CA-based company an opportunity to pull ahead of competition in the minimally invasive glaucoma surgery (MIGS) market. Glaukos...

Misinterpretation of Jaundice Meters Triggers a Recall
Draeger Medical Systems is recalling its Jaundice Meter JM-103 and JM-105 models after some users have misinterpreted display messages that have resulted in serious injuries, according to an FDA notice.The Jaundice Meters are used to measure bilirubin ...

Why Engineers Should Think Like Machinists
Producing a successful part requires a process that transforms raw materials into a final product that satisfies design requirements while taking into account both technological and geometric constraints. But, more than that, a truly successful process...

How Clean is Clean Enough?
ISO 19227 Implants for Surgery--Cleanliness of Orthopedic Implants--General Requirements is a long-awaited guidance document that was finalized and published early 2018. This guidance document is intended to assist orthopedic medical device manufacture...

Is Eversense the Latest Game Changer in the Diabetes Market?
Senseonics’ newly approved Eversense implantable continuous glucose monitoring (CGM) system could be in patient’s hands as early as next month. Tim Goodnow, the Germantown, MD-based company’s president and CEO spoke with MD+DI just a few hours removed ...

Medtronic and IBM Launch a Sweet New Diabetes App
Artificial intelligence continues to prove valuable across many healthcare specialties, but diabetes management really seems to stand out as an area where AI can truly make a direct impact on patient lives.The latest example of the industry embracing A...

Supplier Stories for the Week of June 17

Bridging the Healthcare Interoperability Gap
Interoperability has been a major challenge in healthcare since the early days of electronic medical records. A 2015 survey of nurses found that the lack of interoperability between medical devices and electronic health records is not only burdensome f...

JenaValve Keeps Steady Pace in the TAVR Market
JenaValve Technology is making steady progress in the development of its next-generation transcatheter aortic valve replacement (TAVR) system. The Irvine, CA-based company said it has implanted the initial patients in a CE mark study for the treatment ...

MedAware Uses AI to Tackle Medical Errors and Opioid Epidemic
Artificial intelligence has been used in a wide variety of devices and services in healthcare. MedAware is using AI and machine learning to help tackle medication errors and abuse of opioids. The Raanana, Israel-based company will collaborate with Alls...

Senseonics Wins Nod for Implantable Long-Term CGM
Senseonics Holdings said it has received a PMA for the Eversense Continous Glucose Monitoring (CGM) system. The Germantown, Md-based company said the system is the first and only CGM to feature an implantable glucose sensor and provide long-term contin...

Zimmer Biomet Cancels BoneSupport Orders
Swedish orthobiologics company BoneSupport has decided to cut out the middleman and set up its own U.S. distribution network to sell its Cerament bone void filler in the United States.The Lund, Sweden-based company currently has an exclusive distributi...

Considering Market Access Risk as Part of Today’s M&A Process
The medical devices market experienced steady growth throughout 2017, with deals reached between some of the largest players in the market. The story has not changed much over the first six months of 2018, as the appetite for mergers and acquisitions (...

Medtronic’s Momentum in Innovation Continues
Medtronic seems to be on a roll when it comes to innovation. The Dublin-based company has received the greenlight from FDA for an expanded indication of the Kyphon HV-R Bone Cement.Under the new indication, Medtronic can market Kyphon for the fixation ...

Monitoring is Key in Precipio’s Liquid Biopsy Success
The liquid biopsy market has expanded greatly in the past few years. From billion-dollar financings to highly publicized spinouts – the space has managed to attract quite a bit of attention and change the dynamic of diagnostics.Earlier this week, Roche...

Searching for the Future of Diabetes Management
The future of diabetes management could be coming soon. A global innovation competition is underway to find digital solutions that can help transform type 2 diabetes management.Type 2 diabetes currently accounts for around 90% of the estimated 425 mill...

Gold Medal Win Propels Tegra Medical Co-op to National SkillsUSA Competition
Ethan Blake wins gold at SkillsUSA

MDEA Winner Shows the Value of Nonsurgical Robots in Healthcare
Equashield is proving that robots aren’t limited to just helping with surgeries in the healthcare industry. The Port Washington, N.Y.-based company and Gold winner for MDEA under the Non-Surgical and Hospital Supplies category has developed the Equashi...

Medtronic's New Diabetes App Is Next-Level Personalized Care
Diabetes is among the most data-intensive chronic conditions that exist today, which is why so many digital health technology companies are clamoring to be part of the solution for the millions of people living with the condition. And as MD+DI explored...

NA Looks to Lead Robotics-Based Ultrasound Revolution
Neural Analytics is bringing robotics to the world of ultrasound through its NeuralBot system. The Los Angeles, CA-based company said it has both CE mark and FDA clearance for the technology, which is an ultrasound guidance device to observe blood flow...

Roche Is Willing to Pay a Pretty Penny for the Rest of Foundation Medicine
Roche already owns a majority stake in Foundation Medicine, but now the Swiss company wants to buy the rest of the genomic diagnostics company, and it is willing to pay a pretty penny to do so.Roche agreed to pay $137 a share to buy the rest of Cambrid...