George Tidmarsh, the FDA's top drug regulator, has been placed on leave after being accused of abusing his regulatory ...

One day this summer, Pat McAfee, the former NFL punter turned ESPN personality, interviewed New York Jets cornerback Sauce Gardner about his partnership with Q-Collar, the only medical device cleared ...

With the US Food and Drug Administration’s (FDA) September 9, 2025 announcement that it will increase its enforcement of the Federal Food, Drug, and Cosmetics Act (FFDCA), its rules governing ...

The collaboration will facilitate the provision of secure over-the-air software updates for connected devices.

43,221 model year 2015 to 2017 Toyota Yaris hatchbacks are being recalled due to airbags that might fail to deploy. Faulty wire harnesses inside the airbag sensors within the front doors could ...

Opinion: Companies developing AI-enabled health-care technologies should treat regulatory and IP strategies as parallel, ...

The FDA has sent Philips a warning letter over three ultrasound and enterprise informatics facilities in the U.S. and the Netherlands.

Marlborough-based medical device manufacturer Hologic has been issued a warning letter from the U.S. Food and Drug Administration concerning its BioZorb Marker, a device originally recalled in March.

This is not just about one device. It’s about what happens when institutions grow comfortable living in their own ambiguity and hiding behind opacity.” ...

Being pricked by tiny needles may sound like a strange way to make your skin look better, but that's the concept behind a skin care technique called microneedling.