Nearly a third of FDA medical device adverse events reported late: study
Reports on medical device adverse events widely exceed FDA deadlines, according to a recent study published in the BMJ. Read ...
MedTech Dive1d
Dr. Oz stresses need for faster Medicare coverage of new devices during confirmation hearing
Mehmet Oz, President Trump’s pick to lead the CMS, said Medicare beneficiaries should have quicker access to new medical ...
US FDA says shortage of dialysis device component to extend through early fall
The U.S. Food and Drug Administration said on Friday that supply interruptions of hemodialysis bloodlines, a key component in ...
Barriers To Adopting Disruptive Technologies In Healthcare And How To Overcome Them
Proving your product to be safe and effective while also getting buy-in from the healthcare ecosystem are only some of the ...
Medical Device Network on MSN2d
FDA approves early feasibility study of Valcare’s transcatheter device
The US Food and Drug Administration (FDA) has granted approval for Valcare Medical’s investigational device exemption application, allowing it to begin an early feasibility study of its transcatheter ...
FDA warns of scramble for work and parking space in Monday return to office
The U.S. Food and Drug Administration told staff this week it cannot guarantee work space or parking spots among the hurdles ...
MassDevice2d
Lifeward wins FDA nod for next-gen exoskeleton
Lifeward announced today that it received FDA 510(k) clearance for its latest-generation personal exoskeleton device, ReWalk ...
Lifeward Up 37%, Volume Tops 95.5M Shares as FDA Clears ReWalk 7
Last week, Lifeward said full-year revenue rose to $25.7 million from $13.9 million. It said ReWalk Personal Exoskeleton sales increased by 130% in 2024, fueled by recently established Medicare ...
STAT2d
Study reveals how often medical device makers report safety incidents late to FDA
Most medical devices in the United States come to market with limited clinical data, and device surveillance is viewed as a ...
Trump’s FDA and NIH picks clear committee, teeing up final Senate confirmation
The Senate Health, Education, Labor, and Pensions Committee approved Dr. Jayanta Bhattacharya’s nomination to be NIH director ...
STAT3d
Trump’s picks to run FDA and NIH win approval from Senate’s health committee
Jay Bhattacharya, nominee for National Institutes of Health director, and FDA pick Marty Makary clear key Senate committee.
FDA Issues Clearance for ReWalk 7 Exoskeleton
MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, March 13, 2025 (GLOBE NEWSWIRE) -- Lifeward Ltd., (Nasdaq: LFWD) (“Lifeward” or the “Company”), a ...