FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...

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 ...

The FDA’s call for feedback is informed by evidence that the performance of AI-enabled medical devices can change over time. As the agency explained in its request for comment, factors such as changes ...