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

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

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 ...

Shares of Intuitive Surgical (ISRG) slipped in the morning trading on Wednesday after the U.S. FDA said that the company has issued a safety alert linked to a defective product associated with its da ...

This three-part series reviews how the Food and Drug Administration’s (FDA) January 2026 guidance, “General Wellness: Policy for Low Risk ...

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 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, ...

Opinion: Medical device companies can create a competitive advantage by leveraging data to strengthen compliance programs and by ensuring effective oversight of quality and regulatory reporting ...

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 ...