SimBioSys has won 510(k) clearance from the FDA for TumorSight Risk, a prognostic tool that estimates breast cancer recurrence risk using imaging hospitals already collect. It is, by the company’s account, the first AI-powered, MRI-derived assessment of its kind.
The software reads routine breast MRI together with pathology and clinical records to build a personalized five- and ten-year outlook for women with HR-positive, HER2-negative Stage I to IIIA disease, a subtype covering roughly 75 percent of US breast cancers. TumorSight Risk returns a score from zero to 100 and sorts patients into high, intermediate or low risk. It builds on the company’s cleared TumorSight Viz surgical planning platform and adds spatial AI modeling of the tumor and surrounding tissue.
Underpinning the clearance is a blinded, multi-institutional validation study covering 2,129 patients. It drew on four sites: Mayo Clinic, Emory University, Stanford Medicine and Mercy Medical Cedar Rapids. The findings were presented at the 2026 ASCO Annual Meeting.
Today’s recurrence checks lean on clinicopathologic features and tissue-based genomic assays. Genomic testing brings cost, logistics and turnaround burdens, and certain groups, premenopausal and lymph node-positive women among them, have had fewer validated options. A tool that works from existing scans could widen that field. Mayo Clinic holds a financial interest in SimBioSys.
