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 ...
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 ...

FDA Clearance for HeartBeam (NASDAQ: BEAT) Highlighted in Medical Device Approvals Roundup

HeartBeam (NASDAQ: BEAT) was among the medical device companies highlighted in a Jan. 8 report by Modern Healthcare by ...
MassDevice

FDA warns on heart pump purge cassette issue from J&J’s Abiomed

The FDA today issued a warning related to certain heart pump technologies made by Johnson & Johnson MedTech's Abiomed unit.
Becker's Hospital Review

Where the FDA’s Breakthrough Devices Program stands: 6 notes

Where FDA breakthrough devices stand through 2025: growth, authorizations, leading specialties, AI trends, and qualification pathways explained.
Mad in AmericaOpinion

The FDA Allows Ineffective Devices to Come to Market

The main take-home message is that regulatory approval doesn't mean a device works. It means it's safe,” according to Katya ...
Yahoo

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