On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical ...

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

Dublin, Jan. 07, 2026 (GLOBE NEWSWIRE) -- The "IQ, OQ, PQ in the Verification and Validation Process (Jan 28, 2026)" training has been added to ResearchAndMarkets.com's offering. This course will ...

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

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

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

这个发现让我既意外又释然。意外的是，被行业奉为“红线”的CSV验证，竟从未成为FDA的直接处罚靶点；释然的是，这恰好印证了我多年的判断：CSV更多是行业内人为制造的焦虑，脱离这种束缚，才能真正发挥电子实验记录本（ELN）的价值——而这，恰恰契合FDA等法规制定者保障药品质量的初心。

FDA Commissioner Marty Makary announced Tuesday that wearable devices providing non-medical-grade information will not be subject to FDA regulation as the agency moves to clarify its approach to ...