Fierce Healthcare

FDA paves way for more consumer wearables to hit the market, eases regulation of AI-enabled devices

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

Nearly a third of FDA medical device adverse events reported late: study

Nearly a third of medical device adverse events were not submitted to the FDA within a 30-day regulatory window, with most ...
Reason

Chatbots Are Not Medical Devices

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 ...