Medical Device Network on MSN15h
Nearly a third of FDA medical device adverse event reports filed lateA new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...
The FDA stated that its published medical device cybersecurity requirements from 2023 do include AI in a broad sense. However ...
Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to ...
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
Jay Bhattacharya, nominee for National Institutes of Health director, and FDA pick Marty Makary clear key Senate committee.
Most medical devices in the United States come to market with limited clinical data, and device surveillance is viewed as a key way to keep patients safe. But the FDA’s system for collecting data and ...
MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, March 13, 2025 (GLOBE NEWSWIRE) -- Lifeward Ltd., (Nasdaq: LFWD) (“Lifeward” or the “Company”), a ...
The FDA issued a notice deeming a recall of the Intuitive Surgical (Nasdaq:ISRG) da Vinci 5 surgical robot system Class II.
The draft guidance addresses concerns that pulse oximeters are less accurate for people with dark skin tones. Experts raised ...
Lifeward announced today that it received FDA 510(k) clearance for its latest-generation personal exoskeleton device, ReWalk ...
Key Takeaways DexCom received a warning letter from the Food and Drug Administration following inspections of two of its ...
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