FDA clears SimBioSys AI tool for breast cancer recurrence risk

SimBioSys received FDA 510(k) clearance for TumorSight Risk, a cloud-based AI device that uses breast MRI, pathology and clinical data to estimate 5- and 10-year recurrence risk. It is indicated for hormone receptor-positive, HER2-negative Stage I–IIIA breast cancer, about 75% of U.S. cases.

• Clearance letter dated September 25, 2026; premarket notification filed January 5, 2026
• Score 0–100: above 35 High, 20–35 Intermediate, 20 or below Low
• Validation in 2,129 patients: high-risk group had 3.3x higher recurrence risk
• Cleared for GE and Siemens 1.5T and 3T MRI scanners