FDA clears use of AI tool designed to predict whether breast cancer will recur

The U.S. Food and Drug Administration has given clearance for the use of an AI tool designed to help predict the chances that breast cancer will come back after treatment, the product’s maker says. SimBioSys, a Chicago-based company specializing in AI-driven medicine, announced the clearance for its TumorSight Risk software. The software uses data that includes age, race, cancer stage, nodal status and grade, and MRI data from previously diagnosed invasive breast cancer patients. The software generates 5-year and 10-year risks of breast cancer recurrence, FDA documents state. It provides a score from 0 to 100 that establishes a risk category of "high," "intermediate" or "low" risk. The company says it can predict the risks based on data that has already been collected rather than requiring any additional procedures, tissue shipment or specialized hardware.