Nearly a third of FDA medical device adverse events reported late: study
Nearly a third of medical device adverse events were not submitted to the FDA within a 30-day regulatory window, with most ...
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 ...
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 ...
Examining The FDA's Recommendations For AI-Enabled Medical Devices
The FDA stated that its published medical device cybersecurity requirements from 2023 do include AI in a broad sense. However ...
STAT2d
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.
More than 1.2 million medical device side-effect reports not submitted within legal timeframe, analysis finds
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
MedPage Today on MSN3d
FDA's Deadline Ignored in Nearly 30% of Device Safety Reports
Nearly 10% of postmarket device safety reports in MAUDE were submitted over 6 months after the safety event occurred.
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 ...
JD Supra2d
FDA Debuts a New Communications and Compliance Tool for Device Data Integrity Concerns
Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to ...
JD Supra1d
FDA’s Backup LDT Enforcement Method: Specimen Collection Kits
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...
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 ...
MassDevice2d
FDA says Intuitive da Vinci 5 foot pedal recall is Class II
Class II recalls — a grade below the most serious Class I recalls — reference a situation in which the use of or exposure to ...