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FDA clears SimBioSys's breast cancer risk software
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Fusion42 · 17 October 2026 · Fusion42 review
SimBioSys, a Chicago-based AI developer, has received FDA 510(k) clearance for TumorSight Risk, software that predicts breast cancer recurrence risk using breast MRI, pathology, and clinical data to generate a prognostic score for hormone receptor-positive, HER2-negative breast cancer patients.
This Wire brief sits within Fusion42's coverage of Digital Health, and 6 sources have reported it between 15 Oct 2026 and 17 Oct 2026.
◆ ◆ The Wire takeaway
You can now build tools that offer pre-surgery breast cancer recurrence risks without extra tissue samples, opening access to oncologists focused on hormone receptor-positive, HER2-negative cases. This clearance creates a sales and integration path for predictive AI software in clinical decision-making.
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6 sources · first reported 15 Oct 2026 · latest 17 Oct 2026
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