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Specialty: Medical Devices
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What ’s the Big Deal about Data in Medtech?
Discussion, “Top 5 Things You Need to Know about the Implantable Internet of Things."
Brian Chapman, partner and leader of ZS’s medtech practice of ZS, attributes today’s focus on data to the intersection of two important things:
"A general recognition that understanding more and connecting actions with outcomes will provide feedback and understanding that will drive standards of care. This is not new, but as capabilities rise in data collection, aggregation, and synthesize rise, and coupled with machine learning, the promise of data in healthcare is becoming even more ...
Source: MDDI - December 20, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Digital Health Source Type: news
Financing Paves Way for Rapid to Enter the U.S. Market
Rapid Medical said it has raised $20 million in a series C round to give its IDE trial a boost. The Yokneam, Israel-based company is developing minimally invasive stroke treatment and protection products.
Rapid has been successfully enrolling patients in the TIGER IDE study in the U.S. since May of 2018.
In addition, the proceeds will be used to develop a commercial presence in the U.S. ahead of regulatory approvals, expanding the company's sales and marketing efforts in Europe, as well as the development of additional innovative products.
The financing round was led by JAM Capital Partners and MicroPort with participation...
Source: MDDI - April 23, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news
Learning to Walk Again
When someone suffers a stroke, he or she often loses some mobility, and some 60 percent of survivors are left with lower-limb deficits. “They usually have one leg that's more impaired than the other leg, and then they undergo rehabilitation and physical therapy. And often they don't fully recover,†said Conor Walsh, professor of engineering and applied sciences at the John A. Paulson Harvard School of Engineering and Applied Sciences and a core faculty member at the Wyss Institute for Biologically Inspired Engineering, in an interview with MD+DI.
But a new device called ReSto...
Source: MDDI - April 17, 2019 Category: Medical Devices Authors: Susan Shepard Tags: Design Source Type: news
ReWalk Robotics raises $4m
ReWalk Robotics (NSDQ:RWLK) has raised approximately $4.3 million in a new round of financing, according to recently posted SEC filings.
In the offering, ReWalk Robotics sold warrants to purchase ordinary shares at a purchase price of approximately $5.20, according to the filing. Warrants offered in the round have an exercise price of $5.14 and are exercisable for 5.5 years from the date of issuance. Warrants were issued on April 5, ReWalk Robotics said.
Money in the round came from three unnamed investors, with the first date of sale noted as having occurred on April 3.
The company is looking to raise an additional appro...
Source: Mass Device - April 9, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics Wall Street Beat ReWalk Robotics Source Type: news
FDA Eyes Tailored Approach to Regulating AI-Based Medical Devices
FDA Commissioner Scott Gottlieb is making the most of his final week at the agency.
In the month that has passed since Gottlieb rattled the medical device industry with news of his impending resignation, the commissioner has issued 18 public statements pertaining to nearly all corners of the agency's realm, from food, tobacco, and cosmetics to drugs and devices. Friday is Gottlieb's last day on the job.
On Tuesday, Gottlieb said the agency will consider a new regulatory framework for reviewing medical devices that use advanced artificial intelligence algorithms. AI has been making headlines in medtech for a whi...
Source: MDDI - April 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Software Source Type: news
FDA goes after California stem cell doc for unapproved breast implant device
The FDA this week sent a warning letter to a Beverly Hills, Calif.-based surgeon for their marketing of an unapproved implantable device, dubbed the Pocket Protector, which the surgeon claims can prevent and treat capsular contracture, or scar tissue tightening, during breast implant procedures.
In its letter, the federal watchdog also accuses the surgeon, Dr. Mark Berman, of “significant deviations from the FDA’s quality system requirements and current good manufacturing practices,” including charges related to the sterility of implantable devices.
“This is not the first time the FDA has notified D...
Source: Mass Device - February 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Featured Food & Drug Administration (FDA) Stem Cells Source Type: news
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 and Medtronic finalized its $49.9 billion Covidien deal in early 2015. Now, Medtronic is paying the price for activities that ev3 allegedly conducted between 2005 and 2009 involving the Onyx Liquid Embolic System.
FDA approved the device in 2005 as a liquid embolization device that is surgically injected into blood vessels to block blood flow to arteriovenous malformations ...
Source: MDDI - December 5, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Medtronic to pay $51m to settle Covidien, ev3 DoJ investigations
Medtronic (NYSE:MDT) said yesterday that it agreed to pay $50.9 million to settle a number of U.S. Dept. of Justice probes into marketing activities from companies it acquired, Covidien and ev3.
Medtronic said that its subsidiary ev3, acquired when the Fridley, Minn.-based medtech giant picked up Covidien in 2015, agreed to plead guilty to a misdemeanor charge related to its marketing of the Onyx Liquid Embolic System, pay $17.9 million and adopt new compliance and reporting terms for three years.
The charges relate to ev3’s marketing of the device for “unproven and potentially dangerous uses,” federal prose...
Source: Mass Device - December 5, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Legal News Medtronic Source Type: news
FDA approves Abbott ’ s HeartMate 3 as a destination therapy
Abbott (NYSE:ABT) said today it won FDA approval for its HeartMate 3 left ventricular assist device, now approved as a destination therapy for patients with advanced heart failure.
With the approval, the Chicago-based company said that the device can now be used in patients not eligible for a transplant as a life-long implant.
“We partner with physicians to holistically develop therapies that benefit patients and achieve better outcomes. The unique design of the HeartMate 3 LVAD—with its Full MagLev technology—takes an established innovation and improves upon it in meaningful ways to help people with advanced he...
Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Abbott Source Type: news
Dynatronics taps ex-NinePoint CEO von Jako as chief exec | Personnel Moves – July 11, 2018
Dynatronics said late last month it tapped former NinePoint Medical CEO Christopher von Jako as its new chief executive officer and board member, succeeding Kelvyn Cullimore Jr. who will stay on the company’s board of directors.
Prior to joining Dynatronics, von Jako acted as prez & CEO of NinePoint Medical. Before joining Nine Point, von Jako also served as prez & CEO of NeuroTherm, prez of ActiViews and held positions with medtech companies including Integra LifeSciences, Covidien and Medtronic.
“After thorough succession planning and a comprehensive search process, the board is pleased to have foun...
Source: Mass Device - July 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News AngioDynamics berkshiresterilemanufacturing Corindus Vascular Robotics Dynatronics Corp Guerbet integer MedPlast Medtronic Myomo Inc NinePoint Medical Inc. Pavmed viant Source Type: news
AI Solutions Continue to Catch FDA & #039;s Eye
FDA has given a nod to yet another artificial intelligence (AI)-based technology. This time the agency has granted a De Novo request to market IDx’s AI-based diagnostic system for the autonomous detection of diabetic retinopathy, which can lead to blindness.
The Coralville IA-based company’s IDx-DR diagnostic received expedited review under the FDA's Breakthrough Devices program.
Earlier this year, the company told MD+DI that it met its endpoints in a pivotal trial of the IDx-DR system. The trial involved 900 diabetes patients at 10 sites. The study was designed to evaluate the diagnostic accuracy of the technology in ...
Source: MDDI - April 12, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news
Stroke Rehab Technology Aims To Speed Healing
Watching someone who has suffered a stroke try to perform everyday actions such as walking down the sidewalk or even bringing a cup to their lips can serve as a sobering reminder of how fragile full and robust health is, and also serves as an inspiration for those dedicated to improving the lives of those patients.
Steven Plymale, recently named CEO of Toronto-based MyndTec, said his reaction to watching videos of patients using the company's MyndMove functional electrical stimulation (FES) rehabilitation system was one of the reasons he joined MyndTec.
"They are very compelling," Plymale said of the demonstration videos,Â...
Source: MDDI - November 22, 2017 Category: Medical Devices Authors: Greg Goth Tags: Electronics Source Type: news
Cheetah Medical raises $12m
Cheetah Medical said today it raised $11.8 million in an expanded Series C funding round as it looks to grow its US footprint.
Financing was provided by existing investors including MVM Life Science Partners, Springfield Investment Management, Fletcher Spaght Ventures, HighCape Partners and Robert Basch Venture Capital, the Newton, Mass.-based company said.
Cheetah Medical provides noninvasive hemodynamic monitoring devices and systems, including its Cheetah Nicom and Starlin SV technologies, which operate around a proprietary algorithm designed to allow physicians to examine a patient’s full hemodynamic profile.
&#...
Source: Mass Device - September 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cheetah Medical Source Type: news
Ex-Invacare chief Mixon pulls the trigger on convertible shares
Invacare (NYSE:IVC) said yesterday that the former chairman & CEO who rescued the company from the doldrums in the 1980s, Malachi Mixon III, is pulling the trigger on the more than 700,000 convertible shares he controls.
The 1-for-1 exchange will take Invacare’s voting power from 40,155,366 votes to 33,820,158 votes, the Elyria, Ohio-based company said.
“The conversion will substantially diminish the significance of the company’s dual class voting structure, as after completion, the holders of the common shares will represent approximately 99.5% of the company’s total outstanding voting power,...
Source: Mass Device - June 1, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Wall Street Beat Invacare Rehabilitation Equipment Source Type: news
CytoSorbents touts Refresh trial study data
CytoSorbents (OTC:CTSO) today presented results from the Refresh trial of its CytoSorb blood purification technology, touting that the trial met its safety goals and that treatment reduced toxic inflammatory mediators during complex heart surgery.
Data was presented at the American Association for Thoracic Surgery’s centennial conference in Boston this week.
The Monmouth Junction, N.J.-based company’s CytoSorb is an extracorporeal cytokine filter, made up of biocompatible, porous polymer beads that use pore capture and surface adsorption to remove toxic substances from the blood and other bodily fluids.
The pr...
Source: Mass Device - May 5, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Clinical Trials CytoSorbents Corp. Source Type: news
