The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to ...

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

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

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI ...

The first draft guidance provides an initial framework for how the agency will assess AI models in drug development, but the ...

Despite the AI hype, the systems require consistent monitoring and staffing to put in place and maintain. The process can be ...

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

Last year ended with warnings about malicious websites parting holiday shoppers with their hard earned cash, and 2025 has ...

As AI is integrated into health care, clinicians can acknowledge the technology’s limitations and help shape its future in medicine, according to experts.Healio, in partnership with LinkedIn News, ...

So far, the FDA has approved the drug only for people who already have HIV that’s resistant to other treatments. But its ...

Irish neurotech company CergenX has received the Breakthrough Device Designation from the US FDA while being accepted into ...

As part of the SC-AI 360 mg weekly maintenance regimen, patients who have completed the biweekly intravenous (IV) initiation ...