The FDA 510(k) clearances for cardiac procedures cover Intuitive's latest-generation da Vinci 5 (DV5) using non-Force ...
The FDA ImportShield Program centralizes import review, increasing processing speed by 66% and volume capacity by 33%, while ...
Woori IO plans to accelerate its noninvasive CGM launch after FDA announced relaxed wearable device regulations.
On January 6, 2026, the US Food and Drug Administration (FDA) revised its final guidance on Clinical Decision Support ...
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 ...
The agency cleared lab-based and point-of-care infectious disease and clinical chemistry tests as well as software for digital pathology.
On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical Decision Support ...
While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.
The FDA clears triage tool by Aidoc that detects 14 acute conditions from CT scans to improve emergency care workflows.
Guidance is not law, and frameworks should evolve. But the symbolism matters. At a moment when AI is entering clinical ...
The FDA’s Center for Devices and Radiological Health has withdrawn its December 2017 final guidance for clinical evaluation ...
FDA updated its General Wellness policy to clarify and take a step back from previous positions on health and wellness technology. The Food and Drug Administration (“FDA”) unexpectedly updated its ...
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