SimBioSys announced on October 15, 2026 that the U.S. Food and Drug Administration has granted 510(k) clearance to TumorSight Risk, an artificial intelligence software device that analyzes breast MRI scans alongside pathology and clinical data to estimate a patient's risk of breast cancer recurrence at five and ten years. In its announcement, the Chicago-based company described TumorSight Risk as the world's first AI-powered, MRI-derived prognostic tool for assessing breast cancer recurrence…
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