FDA's July update lists 211 newly cleared AI-enabled medical devices, with radiology comprising the majority.
Key Details
- 1211 AI-enabled medical devices cleared by the FDA since September 2024.
- 2About 81% of these updated clearances are radiology software products.
- 3QIH (automated radiological image processing) leads with 58 new clearances.
- 4New de novo authorization for Clairity's Allix5 software which analyzes breast cancer risk from images.
- 5Eight image analyzer products for mammography, ultrasound, and radiographs were reclassified from class III to class II in 2024.
- 6FDA 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.
Source
AuntMinnie
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