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

BMI Significantly Impacts AI Accuracy in CT Lung Nodule Detection
New research demonstrates that high BMI negatively impacts both human and AI performance in chest low-dose CT interpretation, highlighting dataset diversity concerns.

Cigna Expands Nationwide Coverage for CT Imaging AI Tools
Cigna will reimburse for CT-based plaque analysis AI software for millions of members nationwide.

AI Model Produces Clinically Acceptable Chest X-Ray Reports
A South Korean study finds that AI-generated chest x-ray reports are nearly as clinically acceptable as radiologist-written reports under standard criteria.