An AI That Reads Breast MRIs to Predict Cancer Recurrence Won FDA Clearance

SimBioSys won FDA 510(k) clearance for TumorSight Risk, the first AI tool that estimates breast cancer recurrence risk from routine MRI scans, validated on 2,129 patients across multiple institutions. It needs no extra procedures or hardware, giving oncologists personalized five- and ten-year risk scores before surgery.