FDA clears tool for assessing breast cancer recurrence risk via MRI

The U.S. Food and Drug Administration has cleared a key artificial intelligence tool for assessing breast cancer recurrence risk via magnetic resonance imaging. 

Chicago-based software developer SimBioSys announced the regulatory win on Oct. 15, with the decision applying to its TumorSight Risk offering. The product analyzes routinely collected breast MRI, pathology and clinical data to generate an individualized prognosis at five and 10 years. 

This gives oncologists objective insight prior to surgery, supporting treatment planning for women with hormone receptor-positive (HR+), HER2-negative Stage 1–3A breast cancer. 

“Achieving FDA clearance of TumorSight Risk marks a defining moment for SimBioSys and for precision breast cancer care,” President and CEO Stacey Stevens said in a statement. “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.”

SimBioSys said it believes this is the world’s first AI-powered, MRI-derived prognostic took for assessing breast cancer recurrence risk. TumorSight works by applying proprietary spatial AI modeling to tumor characteristics, surrounding tissue context and clinical factors. The cloud-based software platform then produces a score from 0 to 100 with a category of high, intermediate or low risk. TumorSight works off already collected data and requires no additional procedures nor specialized hardware 

Its clearance is supported by a blinded, multi-institution validation study of 2,129 patients. Results were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, indicating that the software successfully stratified patients by recurrence-free survival.