New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain ...
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to ...
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued ...
The first draft guidance provides an initial framework for how the agency will assess AI models in drug development, but the ...
On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use ...
You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life ...
Despite the AI hype, the systems require consistent monitoring and staffing to put in place and maintain. The process can be ...
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Tempus AI announces national launch of FDA-approved xT CDx testTempus AI (TEM) announced the national launch of the company’s FDA-approved, NGS-based in vitro diagnostic device, xT CDx.
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, ...
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 ...
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