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Articles tagged with “ai-radiology-devices-fda”

FDA-Approved AI Medical Devices List: Complete 2026 Guide

A 2026 guide to the FDA's AI-enabled medical device list: 1,524 entries reviewed this session, 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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