The FDA has reclassified radiological computer-assisted detection (CAD) and diagnosis (CADx) software from class III (highest risk) to class II (special controls).
Key Details
- 1The FDA finalized the order on June 13, moving CAD/CADx software used in radiology to class II regulation.
- 2Devices affected include software aiding detection and diagnosis on medical images like CT, MRI, and X-ray.
- 3Special controls now apply, such as design verification, validation, and clear labeling requirements.
- 4This change lowers the regulatory burden, enabling access via the 510(k) process instead of De Novo or PMA routes.
- 5Reclassification intends to maintain safety and effectiveness while enhancing patient and industry access to innovative tools.
Why It Matters

Source
AuntMinnie
Related News

AI Platform Triples Functional Independence in UK Stroke Patients
AI brain imaging software deployed by NHS has significantly improved stroke outcomes and functional independence rates in England.

Chatbots Surpass Experts in Explaining MRI Results to Patients
A study found that AI chatbots performed better than medical experts at explaining MRI reports to patients.

Specialized LLM for Radiology Reports Outperforms GPT-4o in Summarization Task
A fine-tuned, domain-specific LLM (LLM-RadSum) outperforms GPT-4o in accurately summarizing radiology reports across multiple patient demographics and modalities.