The Pulse
SimBioSys Wins FDA Clearance for MRI-Based Breast Cancer Risk Tool
The FDA cleared SimBioSys’s TumorSight Risk software to estimate five- and ten-year breast cancer recurrence risk for a defined group of patients. The clearance covers women with HR-positive, HER2-negative stage I–IIIA disease whose lymph-n
AI.info Team · Written with AI ·
“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.”
Stacey Stevens, president and CEO of SimBioSys
The U.S. Food and Drug Administration cleared SimBioSys’s TumorSight Risk on September 25, authorizing the prescription software to estimate breast cancer recurrence risk at five and ten years. The company announced the decision on October 15. The FDA’s 510(k) record lists the decision as “substantially equivalent,” the agency’s finding that the device is comparable to a legally marketed predicate for its stated use.
What TumorSight Risk measures
The software is intended for adult women with previously diagnosed invasive, hormone receptor-positive and HER2-negative breast cancer, stages I through IIIA, with lymph-node status limited to N0 or N1. It combines dynamic contrast-enhanced MRI data with age, race, cancer stage, lymph-node status and tumor grade. The FDA’s 510(k) summary describes a proprietary score from 0 to 100, which places patients into low-, intermediate- or high-risk groups.
The approved score bands are 20 or below for low risk, above 20 through 35 for intermediate risk, and above 35 for high risk. SimBioSys says the tool is built on its FDA-cleared TumorSight Viz platform and can use information collected during routine care without an additional procedure or tissue shipment. The indication is prognostic: it helps inform a physician’s risk-based decisions alongside other clinicopathological factors. It is not a screening test or a stand-alone treatment recommendation.
What the 2,129-patient study found
The FDA summary reports a retrospective validation study of 2,129 patients across four U.S. sites. The patients were diagnosed between 2010 and 2024 and had a pre-treatment MRI available. In the validation group, estimated recurrence risk for the low-risk category was 3.0% at five years and 8.6% at ten years; the intermediate-risk estimates were 5.7% and 13.4%, and the high-risk estimates were 9.8% and 26.4%.
For patients classified as low risk, the study reported a negative predictive value of 97.0% at five years and 91.4% at ten years. For the high-risk group, the positive predictive values were 9.8% and 26.4%, respectively. Those measures describe outcomes in the study population; they do not guarantee an individual patient’s outcome. The study was retrospective, and the clearance record does not establish that using the software improves survival or changes treatment decisions.
FDA clearance sets a defined boundary
The FDA record identifies ArteraAI Breast as the predicate device and places TumorSight Risk in Class II under the pathology software regulation. The decision permits marketing for the indications in the clearance; it is not the same as FDA approval through the premarket approval pathway. SimBioSys describes TumorSight Risk as the first AI-powered, MRI-derived tool of its kind, a company claim rather than a separate FDA designation.
The authorized use is limited by both patient group and data inputs: the software is for adult women with HR-positive, HER2-negative stage I–IIIA disease and N0 or N1 lymph-node status, and uses dynamic contrast-enhanced MRI along with clinical information. Its output is meant to be considered with other relevant factors, not substituted for clinical judgment. The FDA’s labeling states that TumorSight Risk informs prognostic decisions in conjunction with other clinicopathological factors.