FDA posts early alert for safety issue with Impella heart pump devices

Impella devices have been the subjects of a series of Abiomed letters and FDA early alerts and recall notices. In January, Abiomed sent an urgent medical device correction about a malfunction risk ...
Medical Device and Diagnostic Industry (MD+DI)

Understanding FDA's QMSR and Cybersecurity Mandates for Medical Devices

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...
Yahoo

FDA moves to rehire medical device, food safety and other staffers fired days earlier

FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed on Oct. 14, 2015. (AP Photo/Andrew Harnik, File) WASHINGTON (AP) — Barely a week after mass firings at the ...

inHarmony Announces FDA Registration Across Vibroacoustic and Red Light Therapy Product Lines

Vibroacoustic Products Listed as Class I Medical Devices; Red Light Therapy Products Listed as Class II Medical Devices ...
MedTech Dive

FDA breakthrough program starts FY2026 at steady pace

Orthopedics was the most active area over the second half of 2025, with the FDA issuing 13 breakthrough designations to devices in the therapeutic area.
NBC New York

FDA moves to rehire medical device staffers fired only days earlier

Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning Friday night, FDA ...
Penn Live

FDA rehires medical device staffers fired only days earlier

WASHINGTON (AP) — Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning ...