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 ...

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The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...

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

The JP Morgan Healthcare Conference will show us many examples of how AI is affecting Healthcare. Cerebras and Nvidia are ...

BERN, Switzerland , Jan. 22, 2025 /PRNewswire/ -- Risklick, a spin-off from the University of Bern, has launched its latest product, Protocol AI, for medical devices. Protocol AI is the first ...

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI ...

Philips is rapidly embracing artificial intelligence, incorporating the tools into many of its medical imaging systems. The company launched a new MRI scanner, which features a variety of AI tools ...

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

The MHRA has issued fresh guidance to help medical device manufacturers prepare for upcoming regulatory changes.