FDA AI device guide reviews 1,524 entries

A 2026 guide to FDA-approved AI medical devices reviews 1,524 entries from the FDA’s AI-enabled medical device list. The guide focuses on how devices move through the 510(k) and De Novo pathways, highlighting the regulatory routes used for AI-enabled tools in clinical settings.

Radiology accounts for 76 percent of the listed devices, underscoring the specialty’s dominant role in FDA-cleared AI medical technology. The guide also notes evidence gaps discussed in JAMA Health Forum and points to landmark clearances, including LumineticsCore and Aidoc CARE, as examples of notable authorizations in the category.