FDA clears SimBioSys's breast cancer risk software

AuntMinnie.com staff writers
Oct 16, 2026

Chicago-based AI developer SimBioSys has received U.S. Food and Drug Administration (FDA) 510(k) clearance for TumorSight Risk, software that combines breast MRI, pathology, and clinical data to estimate a patient’s risk of breast cancer recurrence at five and 10 years. 

The cloud-based software is intended as a prognostic indicator of recurrence-free survival in adult women with hormone receptor-positive, HER2-negative stage I to IIIA breast cancer. It generates a score from 0 to 100 and a high-, intermediate-, or low-risk classification. Results can be available before surgery, with no additional procedure or tissue shipment required, according to the company. 

TumorSight Risk builds on the company’s FDA-cleared TumorSight Viz surgical visualization platform. 

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