FDA Clears First MRI-Derived AI Software for Assessing Breast Cancer Recurrence Risk

The Food and Drug Administration (FDA) has issued 510(k) clearance for TumorSight Risk, an AI-enabled software that can provide long-term assessments of breast cancer recurrence risk based on breast MRI scans, clinical factors and pathology.

SimBioSys, the developer of the TumorSight Risk software, said the software’s proprietary spatial AI modeling incorporates tumor characteristics, the context of surrounding tissue and clinical factors to derive a 0-100 score for providing low-, intermediate- and high-risk classification for recurrence risk at five and 10 years.

Geared to adult women with hormone receptor positive (HR+), HER2-negative stage 1-IIIA breast cancer, the TumorSight Risk software was the subject of a multicenter trial involving over 2,100 patients. In trial findings presented at the American Society of Clinical Oncology (ASCO) conference earlier this year, researchers found that each 10-point increase in the scoring system for the TumorSight Risk software was associated with a 22 percent increase in recurrence risk.

“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,” noted Stacey Stevens, the president and CEO of SimBioSys. “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.”