News

As FDA slashes workforce, number of new medical devices reaching the public has fallen
U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low ...
Medical Device Network on MSN22d
FDA tags Medtronic embolisation device recall as Class I
Medtronic initiated the recall of certain Pipeline Vantage embolisation devices in January 2025 following reports of four patient deaths.
Manila Standard1mon
FDA goes digital with eServices Portal System
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device Notification (CMDN) for Class A ...
Yahoo Finance28d
Nearly a third of FDA medical device adverse event reports filed late
Almost a third of medical device adverse events (AEs) were reported by manufacturers later than the US Food and Drug Administration’s (FDA) required 30-day window across a three-year period ...
People21d
FDA Recalls Nearly 200,000 Cans of Green Beans for Potential Contamination
A Class II FDA classification is issued for devices “for which general controls alone are insufficient to provide reasonable assurance of the safety and effectiveness of the device,” according ...