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 ...
Medical Device Network on MSN9h
FDA approves early feasibility study of Valcare’s transcatheter deviceThe 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 ...
MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, March 13, 2025 (GLOBE NEWSWIRE) -- Lifeward Ltd., (Nasdaq: LFWD) (“Lifeward” or the “Company”), a ...
Nearly 10% of postmarket device safety reports in MAUDE were submitted over 6 months after the safety event occurred.
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
Over 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) within the deadline set by federal regulations, finds an analysis of recent data ...
As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a Modern Healthcare report.
The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers ...
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device Notification (CMDN) for Class A ...
The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones. Experts ...
The founding director of the FDA’s Office of Biotechnology writes that, with FDA approval of medications ultimately vested ...
DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz.
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