Medical Device Network on MSN1d
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 has approved Valcare Medical’s IDE application, allowing it to begin an EFS of Amend Trans-Septal System.
(Reuters) -The U.S. Food and Drug Administration told staff this week it cannot guarantee work space or parking spots among ...
The FDA stated that its published medical device cybersecurity requirements from 2023 do include AI in a broad sense. However ...
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to ...
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 ...
The Senate Health, Education, Labor, and Pensions Committee approved Dr. Jayanta Bhattacharya’s nomination to be NIH director ...
MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, March 13, 2025 (GLOBE NEWSWIRE) -- Lifeward Ltd., (Nasdaq: LFWD) (“Lifeward” or the “Company”), a ...
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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