FDA clears SimBioSys’ TumorSight Risk AI to predict 5- and 10-year breast cancer recurrence

SimBioSys said the FDA 510(k) clearance announced on 2026-10-15 is supported by a blinded, prospectively-designed retrospective, multi‑institutional validation study of 2,129 patients from Mayo Clinic, Emory University, Stanford Medicine and Mercy Medical Cedar Rapids. The company describes TumorSight Risk as cloud-based software that uses proprietary spatial AI modeling to produce a 0–100 score and a categorical high/intermediate/low risk classification, and is intended as a prognostic indicator of recurrence-free survival at five and ten years.

According to SimBioSys’ announcement, results presented at the 2026 American Society of Clinical Oncology meeting showed that each 10-point increase in the 0–100 score was associated with a 22% increase in relative recurrence risk; patients classified as high risk had a 3.3-fold greater risk of recurrence than those classified as low risk. The company reported estimated five-year recurrence risks ranging from 2.2% (scores 0–10) to 13.6% (scores 58–100), and ten-year risks ranging from 6.2% to 34.2% across those score groups. SimBioSys said the tool uses data already collected in routine care (breast MRI), requires no additional procedure or tissue shipment and is designed to deliver results within standard clinical workflows. WISH‑TV additionally reported that SimBioSys built the tool using NVIDIA technology and that, per the article, it can provide results in a couple of hours prior to surgery compared with standard tests that require surgical tissue and can take weeks (WISH‑TV). The company’s press release discloses a Mayo Clinic financial interest.

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