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 ...

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

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI ...

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...

In today’s digital age, the United States’ technological competitiveness holds a pivotal position on the global stage. Behind ...

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

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 ...

Protocol AI accelerates clinical trial development and patient access to medical devices BERN, Switzerland , Jan. 22, 2025 /PRNewswire/ -- Risklick, a spin-off from the University of Bern ...

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