Stacey Stevens

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FDA clears first AI-powered MRI-derived breast cancer recurrence risk tool

Leading the company through the FDA clearance

The Food and Drug Administration cleared TumorSight Risk, the first AI tool that estimates breast cancer recurrence from an MRI a patient already has. SimBioSys's software turns routine MRI, pathology and clinical data into five- and ten-year recurrence estimates, available before surgery.

Updated Oct 19