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
This regulatory change will significantly streamline the approval process for imaging AI developers, reducing time-to-market and promoting innovation. For radiologists, it could lead to faster clinical adoption of advanced CAD tools, with maintained safety standards.
Source
AuntMinnie
Related News
•AuntMinnie
Machine Learning Model Enhances Risk Stratification for Prostate MRI
Researchers developed machine learning models that outperform PSA testing in predicting abnormal prostate MRI findings for suspected prostate cancer.
•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
Nvidia Unveils Explainable AI Models Mimicking Radiologist Reasoning
Nvidia introduces Clara Reason, a suite of explainable AI models designed to emulate radiologist workflows for interpreting medical images.