SimBioSys announced on October 15, 2026, that the FDA had granted 510(k) clearance to TumorSight Risk. The FDA decision was dated September 25.
The software combines routinely collected breast MRI, pathology and clinical information to estimate five- and ten-year recurrence risk for adult women with HR-positive, HER2-negative Stage I–IIIA breast cancer.
It produces a score from 0 to 100 and a low-, intermediate- or high-risk category. The tool is intended to support—not replace—clinical judgment and other risk information.
In a retrospective, multi-institutional validation study of 2,129 patients, people classified as high risk had 3.3 times the recurrence risk of those classified as low risk. Each 10-point score increase was associated with a 22% increase in relative recurrence risk.
TumorSight Risk is built on SimBioSys’s TumorSight Viz platform and uses NVIDIA technology. It works with existing clinical data, so it does not require an extra scan or procedure.
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