MedTech Dive

Medtech industry calls for FDA staffing transparency in MDUFA talks

Medical device lobbyists called for more staffing transparency in user fee negotiations with the Food and Drug Administration ...
Medical Device Network on MSN

LifeVac receives FDA De Novo classification for anti-choking device

LifeVac is approved for use as a single-use, non-powered, non-invasive airway clearance device.

Airiver Medical receives FDA breakthrough device status for DCB

The DCB currently remains an investigational device and is not available for sale in the US. "Airiver Medical receives FDA ...
JD Supra

FDA medical device inspections in 2025: What we're seeing, what we expected, and why you need the right expertise now

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

The Life-or-Death Stakes of Medical Device Cybersecurity

Connected medical devices improve patient care but introduce severe cybersecurity risks that require stringent regulatory ...
JD Supra

FDA updates medical device user fee guidance for small businesses, tightening some rules for reductions and waivers

On July 31, 2025, the U.S. Food and Drug Administration (FDA) issued its final guidance document “Medical Device User Fee Small Business Qualification and Determination,” which supersedes its previous ...
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 ...
Fierce Biotech

FDA issues safety alert on Trividia blood glucose monitors

The FDA is flagging a high-risk issue with blood glucose monitors manufactured by Trividia Health that the company says is tied to 114 serious injuries and one death since the devices’ launch 12 years ...

Texas Governor orders cybersecurity audit of Chinese medical devices over data breach risks

Texas Governor Greg Abbott has directed state health agencies and universities to review cybersecurity policies and inventory Chinese-manufactured medical devices following federal warnings that the ...
MobiHealthNews

FDA floats new draft guidance, created by international group, on software as a medical device

The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...
MD&M East

FDA’s Clash With Consumer Tech: Then, Now, And What’s To Come

It’s no question that technology is expanding at a rapid pace, impacting devices in all fields, from manufacturing to medicine. When new developments come to fruition in the medical space, companies ...
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 ...