New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain ...

KFDA sets global standard for generative AI medical device approval guidelines Health authority introduces pioneering ...

Artificial Intelligence (AI) has transformed various industries, and healthcare is no exception. Among the many advancements, ...

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...

South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help ...

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI ...

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued ...

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life ...

Tempus AI says the app, olivia, is designed to centralize patients’ health data and make it accessible through artificial ...

My primary care physician has been using an AI-assisted device during our office visits that transcribes and records our ...