FDA clears first MRI-based AI tool to predict breast cancer recurrence risk
The FDA granted 510(k) clearance to SimBioSys's TumorSight Risk, cloud-based software that analyzes a patient's existing breast MRI along with pathology and clinical factors (age, race, tumor stage, nodal stage, histologic grade) to estimate the risk of breast cancer recurrence at 5 and 10 years. It is cleared for adult women with hormone receptor-positive, HER2-negative stage I-IIIA breast cancer, a subtype representing about 75% of US breast cancers. The software produces a 0-100 score and a high-, intermediate- or low-risk classification, with results available before surgery and no extra scan or tissue shipment needed. The company says clearance was supported by a blinded, multi-institutional validation study of more than 2,100 patients from Mayo Clinic, Emory University, Stanford Medicine and Mercy Medical Center Cedar Rapids, where each 10-point increase in score corresponded to a 22% rise in relative recurrence risk.
Why it's notable: It gives oncologists an FDA-cleared, MRI-derived recurrence-risk estimate from imaging most patients already have, potentially informing treatment-intensity decisions for the most common breast cancer subtype without added biopsies or tests.