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The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to ...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 ...
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CergenX wins FDA breakthrough designation for neonatal EEG assessment toolTrained on large databases of brain data among newborns, CergenX’s Wave device uses AI to help with earlier detection of ...
On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use ...
Despite the AI hype, the systems require consistent monitoring and staffing to put in place and maintain. The process can be ...
Irish neurotech company CergenX has received the Breakthrough Device Designation from the US FDA while being accepted into ...
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, ...
You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life ...
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