SimBioSys Gets FDA Clearance for AI Breast Cancer Recurrence Tool

Oct 15, 2026
TumorSight Risk analyzes breast MRI, pathology and clinical data to estimate recurrence risk at five and ten years for certain patients with early stage breast cancer.

SimBioSys said in a press release that the FDA granted 510(k) clearance to TumorSight Risk, software that estimates breast cancer recurrence risk using AI. The tool analyzes breast MRI, pathology and clinical data to provide five and ten year estimates for adult women with HR positive, HER2 negative Stage I to IIIA breast cancer.

TumorSight Risk produces a score from zero to 100 and classifies patients as having low, intermediate or high risk. It uses information collected during routine care and requires no additional procedure, tissue shipment or specialized hardware. Clinicians should consider its result alongside other clinical and pathology factors.

The clearance was supported by a blinded retrospective validation study involving 2,129 patients from four medical institutions. Patients 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 percent increase in relative recurrence risk.

The study results are reported by SimBioSys and come from a retrospective analysis rather than a prospective trial.

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