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Empowering Patients to Take Care of Their Hearts
Hypertension affects about 103 million Americans, according to the American Heart Association (AHA). Atrial fibrillation (AFib), which is often associated with hypertension and could affect up to 6 million people per CDC statistics, can be asymptomatic, so patients may be unaware they have it. The CDC also reports that more than 600,000 Americans die each year from heart disease, and coronary artery disease is the most common type of such disease. Also impacting the heart is diabetes—and more than 100 million Americans suffer from it, the CDC reported. “Heart dise...
Source: MDDI - September 30, 2019 Category: Medical Devices Authors: Daphne Allen Tags: 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 amends soft exoskeleton research, licensing deal with Harvard
UPDATE: Corrected to reflect that ReWalk Robotics was amending an earlier deal. ReWalk Robotics (NSDQ:RWLK) has inked a set of amendments to its collaborative research and exclusive licensing agreement with Harvard Collage related to the development of its soft-suit exoskeleton, according to a recently posted SEC filing. Through the original collaborative deal, both groups will join to aid in the development of soft-suit exoskeleton technologies designed to treat lower limb disabilities, the Marlborough, Mass.-based company said. The suit is intended to treat stroke, multiple sclerosis, mobility limitations for the elderl...
Source: Mass Device - July 2, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Research & Development Robotics ReWalk Robotics Source Type: news

Finding Good Candidates for Risk-Sharing Arrangements
Continued from Part I that discusses the tools device manufacturers can use to manage risk How to find good candidates? Not all devices are created equal. But how can device manufacturers identify the low-hanging fruit for a risk-sharing arrangement? Needless to say, the more characteristics a product has that are associated with successful risk-sharing arrangements, the more such an arrangement is likely to succeed. To illustrate, in Exhibit 1, we chart a select number of risk-sharing arrangements established since 2015 along two key dimensions: product effectiveness and time needed to observe expected outcomes. The findi...
Source: MDDI - April 3, 2018 Category: Medical Devices Authors: Harry Liu and Christine Chen Tags: Contract Manufacturing Design Source Type: news

AI Solution Detects Autism in Toddlers
A digital healthcare startup is using an artificial intelligence (AI) platform to help aid in the detection of autism. Palo Alto, CA -based Cognoa said FDA has classified the algorithm-powered solution as a Class II diagnostic medical device. The FDA designation gives the company a path to get full clearance as a medical diagnostic for autism. “The goal actually is this summer to submit to the FDA to get full clearance under a de novo as a medical diagnostic,” Sharief Taraman, vice president of medical at Cognoa, told MD+DI. “I think we should be able to get that at the end of the year or by 2019.” Network with y...
Source: MDDI - February 22, 2018 Category: Medical Devices Authors: Omar Ford Tags: Medical Device 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,�...
Source: MDDI - November 22, 2017 Category: Medical Devices Authors: Greg Goth Tags: Electronics Source Type: news

ReWalk Robotics touts Harvard-led Restore soft exosuit study
ReWalk Robotics (NSDQ:RWLK) today released results from a study of a soft suit exoskeleton system designed to aid ambulatory stroke patients, touting that the system was able to facilitate normal walking ability in patients. The study was authored by researchers at Harvard University’s Wyss Institute for Biologically Inspired Engineering and Boston University, and utilized a prototype that Marlborough, Mass.-based ReWalk Robotics plans to commercialize as the Restore system. Results from the study were published in the Journal of Science Translational Medicine. The Restore system is designed to transmit power to ke...
Source: Mass Device - August 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Prosthetics Robotics ReWalk Robotics Source Type: news

ReWalk Robotics inks French distro deal with Harmonie M édical Service
ReWalk Robotics (NSDQ:RWLK) said today it inked an exclusive French distribution deal with Harmonie Médical Service. Through the deal, HMS will operate as sole distributor of the ReWalk exoskeleton systems for individuals with spinal cord injuries in France. The deal includes both the ReWalk Personal and ReWalk Rehabilitation systems for home and clinical use, respectively. “Our partnership with ReWalk is a real opportunity for HMS. We have been working for 30 years in the medical materials domain with people who have lost their mobility. We have always looked for innovative technologies in this domain, especially...
Source: Mass Device - July 11, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Distribution Robotics ReWalk Robotics Source Type: news

ReWalk debuts Restore soft-suit exoskeleton prototype
ReWalk Robotics (NSDQ:RWLK) today debuted the prototype of its Restore soft suit exoskeleton designed to aid stroke survivors. The company presented the prototype alongside collaborators from Harvard University’s Wyss Institute for Biologically Inspirde Engineering, and said it would focus on the suit as a “core company goal” for the fiscal year. “We are thrilled with the progress of the Restore system, which will provide life changing technology to a whole new class of patients facing mobility issues. With the prototype finished, we are eager to begin clinical studies and pursue regulatory approva...
Source: Mass Device - June 19, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics ReWalk Robotics Source Type: news

7 medtech stories we missed this week: June 2, 2017
[Photo from unsplash.com]From Implandata receiving CE Marking to Inolife eyeing up-listing, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Dextera seeks expanded indications for MicroCutter 5/80 stapler Dextera Surgical announced in a June 1 press release that it has filed a 510(k) with the FDA for its MicroCutter 5/80 stapler. The company wants to expand the indications of the MicroCutter 5/80 for use in liver, pancreas, kidney and spleen surgeries. Currently, the staplers are used for transection and resection in multiple open minimally-invasive urologic, thoracic and pediatr...
Source: Mass Device - June 2, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Business/Financial News Clinical Trials News Well Regulatory/Compliance Research & Development c2 Therapeutics Dextera Surgical DreaMed Diabetes EndoGastric Solutions Inc. Implandata Inolife MicroTransponder Inc. Source Type: news

MassDevice.com +5 | The top 5 medtech stories for March 8, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Court clears Caldera’s $12.3m transvaginal mesh settlement A California federal judge last week approved a $12.3 million deal to settle a number of insurance claims over injuries allegedly caused by Caldera Medical’s transv...
Source: Mass Device - March 8, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Layoffs ahead for ReWalk Robotics
ReWalk Robotics (NSDQ:RWLK) is reportedly planning to cut its operating expenses by 30% in 2017, a move that’s slated to include layoffs for an unspecified number of workers. The Marlborough, Mass.- and Israel-based company said it aims to meet its goal partially via a “reduction in staffing.” ReWalk had 87 employees as of December 2015, according to a regulator filing. “In the years since ReWalk received its FDA clearances for spinal cord-injured individuals, we have seen the market evolve, albeit slowly,” CEO Larry Jasinski said in prepared remarks. “Taking an industry-wide assessme...
Source: Mass Device - January 11, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Prosthetics Robotics Wall Street Beat ReWalk Robotics Source Type: news

ReWalk Announces Collaboration With Harvard University's Wyss Institute To Develop Lightweight And Soft Exoskeleton Systems For The Treatment Of Stroke, Multiple Sclerosis And Limited Mobility Patients
ReWalk Robotics Ltd. (Nasdaq:RWLK) ("ReWalk" or "Company"), the leading global exoskeleton developer and manufacturer today announceda collaboration withHarvard University'sWyss Institute for Biologically Inspired Engineering for the licensing of Intellectual Property (IP), and development of concepts and designs of lightweight exoskeleton system technologies for lower limb disabilities.
Source: Medical Design Online News - May 18, 2016 Category: Medical Equipment Source Type: news

ReWalk inks collab deal with Harvard to develop “soft” exosuit
ReWalk Robotics (NSDQ:RWLK) said today it inked a collaborative research with Harvard’s Wyss Institute to develop a lightweight “soft suit” exoskeleton system for lower limb disabilities. The collaboration looks to design a suit to treat stroke, multiple sclerosis and mobility limitations for the elderly as well as other applications. Through the agreement, ReWalk will pay Harvard in quarterly installment payments to fund the research, with reports from the research being relayed between the groups on a regular basis. ReWalk Robotics will be able to negotiate with Harvard to license new inventions create...
Source: Mass Device - May 17, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Prosthetics Harvard University ReWalk Robotics Wyss Institute Source Type: news

Harvard, UMass Collaboration Creates Drug-Device Combination For Stroke Treatment
A newly developed drug-device combination can burrow through a stroke-causing clot while releasing anti-coagulant medication. The injectable nanotherapeutic targets blocked vessels and works in tandem with a temporary endovascular bypass (TEB) procedure to remove clots with fewer side effects than a stent-retriever thrombectomy (SRT).
Source: Medical Design Online News - October 29, 2015 Category: Medical Equipment Source Type: news