SimBioSys receives FDA clearance for Nvidia-powered AI tool to predict breast cancer recurrence

SimBioSys announced FDA clearance for its TumorSight Risk platform, an AI-driven tool that uses MRI, pathology and clinical data to assess the likelihood of breast cancer returning.

The cloud-based software evaluates routinely collected breast MRI scans along with standard pathology and clinical information to generate a personalized prognosis at five and ten years, categorizing patients as high, intermediate or low risk.

The tool is aimed at women with hormone receptor-positive, HER2-negative stage I-IIIA breast cancer, a group that makes up roughly three-quarters of U.S. breast cancer cases, helping oncologists tailor treatment decisions.

Built on the previously cleared TumorSight Viz platform and powered by Nvidia technology, TumorSight Risk applies spatial AI modeling to tumor characteristics and surrounding tissue context, marking a step forward in precision breast cancer care.