STAT

Beyond detection: In the age of clinical AI, what counts as an FDA ‘breakthrough’ medical device?

An analysis of AI-powered devices that received FDA's "breakthrough" label shows a preference for big-picture, multi-problem ...
STAT

FDA’s evolving view of what makes a ‘breakthrough’ device

On top of being a day for brands to post “pranks” on social media, April 1 was also the deadline to apply for the CMMI ACCESS ...
Medical Design & Outsourcing

FDA removes pediatric VADs from device shortage list, adds others

The FDA has removed pediatric ventricular assist bypass devices (VADs) from its device shortage list in an update this month.
Regulatory Affairs Professionals Society

FDA warns device maker, contract testing lab for GMP violations

The US Food and Drug Administration (FDA) has cited a medical device manufacturer and a contract drug testing laboratory for ...
Regulatory Affairs Professionals Society

This Week at FDA: Makary reflects on first year, FDA working to lift peptide restrictions, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
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 ...

DIAGNOS Successfully Completes the Renewal of US-FDA Medical Device Establishment Registration

Diagnos Inc. (“DIAGNOS” or the “Corporation”) (TSX Venture: ADK, OTCQB: DGNOF, FWB: 4D4A), a company dedicated to the early ...
Becker's Hospital Review

Confidential FDA Medical Device Files Accidentally Leaked Online

The Food and Drug Administration is investigating how a contracted document management company accidentally made public 75,000 pages of confidential FDA files related to approval of medical devices, ...
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 ...