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
Related News
•AuntMinnie
AI's Evolving Role in Tackling Radiology Workforce Shortages
AI technologies are emerging as key tools to alleviate radiology workforce shortages by improving efficiency and supporting clinical workflows.
•Radiology Business
Multimodal LLMs Struggle with Radiology Board Image Questions
Latest multimodal large language models show limitations on image-based radiology exam questions.
•Radiology Business
Study Compares Popular LLMs for Communicating Radiology Results
Researchers evaluated ChatGPT, Gemini, and Copilot for explaining radiology reports to patients.