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The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to ...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

Trained on large databases of brain data among newborns, CergenX’s Wave device uses AI to help with earlier detection of ...

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 ...

“Consumer tech trends of 2025 will revolve around creating meaningful local experiences, fostering community connections and ...

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 ...

Among his first actions as president, Donald Trump has rescinded an executive order signed during the Biden administration ...