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 ...

The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic ...

Federal regulators on Thursday approved a new higher-dose version of the blockbuster obesity drug Wegovy that may help users ...

In November, the Food and Drug Administration (FDA) held a Digital Health Advisory Committee meeting where it considered treating artificial intelligence mental health chatbots as medical devices. As ...

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 ...

The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...

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 ...

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 ...

Healthcare systems in North America and Europe are increasingly favoring suppliers who can provide “one-stop” solutions—meaning products that transition seamlessly from emergency stabilization to long ...

Opinion: Medical device companies can create a competitive advantage by leveraging data to strengthen compliance programs and ...