The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to TumorSight Risk, an AI-powered prognostic tool that uses magnetic resonance imaging (MRI) to assess the risk of recurrence in patients with breast cancer.  

Developed by SimBioSys, an AI-driven precision medicine company, the tool estimates the risk of recurrence at 5 and 10 years in women with hormone receptor (HR)–positive, HER2-negative stage I to IIIA breast cancer using breast MRI, pathology, and clinical data. These estimates are intended to support treatment planning before surgery.  

"For the first time, clinicians can use the rich biological and spatial information already captured in a patient's breast MRI—together with standard pathology and clinical factors—to gain personalized insight into recurrence risk. By delivering this intelligence rapidly within the existing care pathway, TumorSight Risk has the potential to expand access to prognostic information and help clinicians and patients approach treatment decisions with greater clarity and confidence," stated Stacey Stevens, President and CEO of SimBioSys.  

TumorSight Risk is a cloud-based software platform that uses proprietary spatial AI modeling to analyze tumor characteristics, surrounding tissue, and clinical factors. The system generates a score from 0 to 100 to classify a patient’s risk of recurrence.  

Supporting Evidence

FDA clearance was supported by findings from a blinded, retrospective, multi-institutional validation study presented at the 2026 ASCO Annual Meeting.  

The study evaluated TumorSight Risk’s 5-year recurrence score in an independent cohort of 2,129 patients with HR-positive, HER2-negative breast cancer who underwent breast MRI before surgery. 

Estimated recurrence-free survival rates at 5 years were 95.5% for low-risk patients and 89.6% for high-risk patients; at 10 years, the corresponding rates were 88.9% and 69.6%. The risk score was strongly associated with recurrence risk, with each 10-point increase corresponding to a 22% increase in the relative risk of recurrence. The association between the risk score and recurrence-free survival remained significant after adjustment for other prognostic factors.  

"Accurately defining recurrence risk is central to individualizing treatment for patients with early stage, hormone receptor–positive breast cancer," said Matthew Goetz, MD, Deputy Director, Mayo Clinic Comprehensive Cancer Center in Rochester, Minnesota, who also presented the findings at the ASCO Annual Meeting. "The multi-institutional validation data show that MRI-derived assessments may provide prognostic information beyond standard clinicopathologic factors. The ability to build on information already available in the diagnostic pathway could offer oncologists a practical new way to refine risk assessment and support more informed conversations with patients."

The company noted that TumorSight Risk is designed to complement existing methods of assessing breast cancer recurrence risk and that its results should be considered alongside other clinicopathologic factors when making treatment decisions. 

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