FDA clears SimBioSys AI software to predict breast cancer recurrence

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to TumorSight Risk, an AI-enabled software developed by Chicago-based SimBioSys. The tool is designed to assess the five- and 10-year risk of breast cancer recurrence in adult women with hormone receptor positive (HR+), HER2-negative stage I-IIIA breast cancer.

The software utilizes proprietary spatial AI modeling to analyze existing breast MRI scans, pathology, and clinical data—including age, race, cancer stage, nodal status, and grade. It generates a score from 0 to 100, classifying patients into low, intermediate, or high-risk categories. Because it relies on data already collected during standard care, the tool does not require additional procedures or specialized hardware.

In a multicenter trial involving over 2,100 patients, researchers found that every 10-point increase in the software's score was associated with a 22 percent increase in recurrence risk. SimBioSys CEO Stacey Stevens stated that the tool provides personalized insight by leveraging biological and spatial information already captured in patient MRIs to assist in treatment decisions.