FDA Clears NVIDIA-Powered AI Tool for Predicting Breast Cancer Recurrence Risk

SimBioSys announced FDA 510(k) clearance for TumorSight Risk, an artificial intelligence platform that estimates the likelihood of breast cancer returning within five and ten years by analyzing existing MRI scans and patient pathology data. The first AI-powered, MRI-derived prognostic tool of its kind targets approximately 74% of U.S. breast cancer cases—those with hormone receptor-positive, HER2-negative Stage I–IIIA disease, a designation affecting hundreds of thousands of patients annually seeking clarity on treatment intensity and long-term outcomes.