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.
FedTech Magazine

FDA Tightens Its Medical Device Cybersecurity Guidance

Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.
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 ...
GlobalData on MSN

FDA approves Anumana’s pulmonary hypertension algorithm

The algorithm integrates with EHR systems and ECG platforms, operating within the health system without external data transfer.
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, ...
Becker's Hospital Review

FDA flags 2 devices after death, injuries reported

FDA flags devices after death and injuries reported involving Intuitive Surgical staplers and Insulet Omnipod 5 Pods, urging ...
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 ...
PBS

AP report: FDA moves to rehire medical device staffers fired only days earlier

Associated Press (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.