Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged sword." ...

On January 6, 2026, the US Food and Drug Administration (FDA) revised its final guidance on Clinical Decision Support ...

A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and ...

Market opportunities arise in providing solutions for cGMP software verification and validation, addressing increased FDA scrutiny. Demand exists for expertise in FDA guidelines, risk management ...

OneMedNet Corporation (Nasdaq: ONMD), a leading provider of regulatory-grade, AI-ready Real-World Data (RWD), today announced that its high-quality, multimodal clinical data supported mlHealth 360 in ...

Woori IO plans to accelerate its noninvasive CGM launch after FDA announced relaxed wearable device regulations.

TechCrunch Disrupt Battlefield 2023 winner, Biotics AI, announced on Monday that it has received FDA clearance for its AI ...

In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight.

Korrapati's implementation work is complemented by industry engagement, including presenting on CSA implementation and roadblocks at professional venues ...

Woori IO, an OSR company developing next-generation noninvasive glucose monitoring technologies, today commented on the U.S.

FDA and EMA have issued 10 guiding principles for AI in drug development with the intended goal of ensuring safety and ...