Radiology Dominates Latest FDA AI-Enabled Device Clearances in July Update
July 14, 2025
FDA's July update lists 211 newly cleared AI-enabled medical devices, with radiology comprising the majority.
Key Details
- 211 AI-enabled medical devices cleared by the FDA since September 2024.
- About 81% of these updated clearances are radiology software products.
- QIH (automated radiological image processing) leads with 58 new clearances.
- New de novo authorization for Clairity's Allix5 software which analyzes breast cancer risk from images.
- Eight image analyzer products for mammography, ultrasound, and radiographs were reclassified from class III to class II in 2024.
- FDA plans to tag devices using foundation models, including LLMs and multimodal AI.
Why It Matters
Radiology continues to be at the forefront of FDA-cleared AI innovation, highlighting the field's rapid adoption of advanced technologies. Monitoring regulatory trends, device reclassifications, and transparency measures is critical for radiology and imaging AI professionals.