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Articles tagged with “510k-clearance-ai-devices”

FDA-Approved AI Medical Devices List: Complete 2026 Guide

A 2026 guide to the FDA's AI-Enabled Medical Device List: 1,614 entries as of the September 2026 update, 510(k) versus De Novo pathways, radiology's 76 percent share, JAMA Health Forum evidence gaps, and landmark clearances including LumineticsCore and Aidoc CARE.

35 min read

7/19/2026

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