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.

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 ...

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 ...

FDA has scrapped a final rule that was implemented in May 2024, which required the application of medical device rules to laboratory-developed tests. The new rule, effective September 19, 2025, ...

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

Integrating AI into medical devices brings the industry a new level of innovation. The benefits can help both providers and patients but also introduce more risk. AI’s application in any technology is ...

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 ...