AI-powered medical wearables and software are flourishing following the FDA’s new hands-off regulatory guidance.
Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged sword." ...
On Jan. 6, 2026, the U.S. Food and Drug Administration (FDA) updated the final guidance documents General Wellness: Policy for Low Risk Devices (the General Wellness Guidance) and Clinical Decision ...
On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical ...
FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health technology and AI policies.
Woori IO plans to accelerate its noninvasive CGM launch after FDA announced relaxed wearable device regulations.
By Puyaan Singh Jan 6 (Reuters) - The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed to support healthy lifestyles, issuing ...
For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...
The agency issued a request for more information that will shape new regulation on ingredient transparency.
An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...
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