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

Many AI-enabled medtech products leverage machine learning or deep learning. In order to address the opaque decision-making ...

Philips’ Shez Partovi said a lot of the company's focus is working to determine how AI can be used to give time back to ...

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...

Doctors have an overwhelming amount of individual patient data and medical research at their disposal to make diagnoses and ...

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

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

TAVIPILOT Soft is said to be a ‘world-first’ provision for real-time surgical guidance during TAVI and TAVR procedures.

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI ...

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

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

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 ...