On October 15, 2026, Chicago-based SimBioSys announced FDA 510(k) clearance for TumorSight Risk, which it describes as the first AI-powered, MRI-derived prognostic tool for breast cancer recurrence. The cloud software combines a patient’s routinely collected breast MRI with pathology and clinical data and returns a score from 0 to 100 plus a high, intermediate or low risk category, as a prognostic indicator of recurrence-free survival at five and ten years. It is cleared for adult women with hormone receptor-positive, HER2-negative Stage I to IIIA breast cancer, a subtype the company puts at about 75 percent of US breast cancers, and its result is meant to be weighed alongside other clinicopathologic factors.
The clearance rests on a blinded, prospectively designed retrospective validation study of 2,129 patients from Mayo Clinic, Emory University, Stanford Medicine and Mercy Medical Cedar Rapids, presented at ASCO 2026. Patients classified high risk had 3.3 times the recurrence risk of those classified low risk, and each 10-point increase in the score was associated with a 22 percent rise in relative recurrence risk. Estimated five-year recurrence risk ran from 2.2 percent for the lowest score band to 13.6 percent for the highest, and ten-year risk from 6.2 to 34.2 percent. The score stayed significant after adjusting for tumor and nodal stage, grade, age, race and treatment (p=0.002). TumorSight Risk is built on SimBioSys’s earlier FDA-cleared TumorSight Viz platform.
Why it matters: recurrence risk for this group usually comes from clinicopathologic features and tissue-based genomic assays that add cost, logistics and turnaround time. An imaging-native score from data already collected, available before surgery and requiring no tissue shipment, is a new kind of AI prognostic device rather than another detection aid.
What it does not show: the validation is retrospective, and the company’s materials do not report a head-to-head comparison with established genomic recurrence tests, nor evidence yet that using the score changes treatment decisions or outcomes. The performance figures come from the company’s announcement.