IMDRF Publishes 2026 Document Implementation Report
IMDRF has published its 2026 Document Implementation Report, providing the self-identified implementation status of IMDRF technical documents across member jurisdictions.
FDA Classifies Radiological Machine Learning-Based Quantitative Imaging Software with Predetermined Change Control Plans as Class II Devices
The FDA has classified radiological machine learning-based quantitative imaging software with predetermined change control plans as Class II medical devices, establishing special controls to support the safe development and regulatory oversight of AI-enabled imaging software.