Radiology accounts for 76% of FDA AI device authorizations

Sep 14, 2026 · Issue 7 · 2 sources, 2 articles

New FDA data show radiology leads authorizations of AI-enabled medical devices, with a 76% share (14 September 2026). The Imaging Wire also compiled a ranking of the leading AI vendors.

Who is affected and how

medtech company

Radiology is the most crowded authorization area, and the FDA list can be used for competitor analysis.

doctor

Radiologists are the professional group most affected by AI.

Sources

• Top 10 AI Vendors by FDA Approvals - The Imaging Wiretheimagingwire.com · Sep 14, 2026
• Radiology holds 76% of FDA's AI device authorizations in new... | Pivot Newspivotnews.ai · Sep 14, 2026

Machine-generated summary based on the titles and excerpts of the source articles. The source article is the authority for the facts. News monitoring, not medical advice: consult a doctor for health decisions.