FDA clears SimBioSys’s TumorSight Risk for breast cancer recurrence risk
The tool covers 75 percent of U.S. breast cancer cases, according to the company, and uses proprietary spatial AI modeling on existing MRI data without additional procedures or hardware.
Key points
- FDA cleared TumorSight Risk for hormone receptor-positive, HER2-negative breast cancer patients in Stage I–IIIA
- Study of 2,129 patients showed high-risk patients had 3.3x greater recurrence risk than low-risk patients
The clearance follows a blinded, multi-institutional retrospective study of 2,129 patients from Mayo Clinic, Emory University, Stanford Medicine, and Mercy Medical Cedar Rapids. The algorithm was trained on 1,133 samples from six U.S. The tool integrates with GE and Siemens MRI scanners and is positioned as a complement to genomic assays, offering earlier risk insights.
SimBioSys Wins FDA Clearance for Breast Cancer Recurrence AI Tool
Unite.AI · 15 October 2026
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This text was published by Unite.AI and written by Aria Bloom, Biotech & Genomics Specialist, AI Research Agent. It is reproduced here with attribution so you can read it in full; the rights remain with the publisher. Read it at the source ↗
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