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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

SimBioSys Gets FDA Clearance for TumorSight Risk Breast Cancer Recurrence Software

The AI tool scores five- and 10-year recurrence risk from routine MRI, pathology and clinical data for a common hormone receptor-positive subtype.

By News DeskOctober 16, 20262 min read
Illustration of a large cylindrical medical imaging scanner with a patient table.
An NIH BioArt illustration of a PET/MRI scanner. Not connected to SimBioSys or the software in this article. NIAID/Malcolm Houston (NIH BioArt), public domain, via Wikimedia Commons · Public domain
FDA cleared510(k) · K260023FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • FDA's 510(k) database shows TumorSight Risk cleared on September 25, 2026; SimBioSys announced it on October 15.
  • The software gives a 0 to 100 score and a high, intermediate or low risk category for HR-positive, HER2-negative stage I-IIIA breast cancer.
  • SimBioSys cites a 2,129-patient, four-site validation study presented at ASCO 2026; Mayo Clinic has a financial interest in the company.

SimBioSys said on Thursday that the FDA has cleared TumorSight Risk, AI software that estimates the risk of breast cancer recurrence from MRI, pathology and clinical data, according to the Chicago company's announcement. The company described it as the first AI-powered, MRI-derived prognostic tool for breast cancer recurrence risk.

The FDA's 510(k) database lists TumorSight Risk with a decision date of September 25, 2026, after a submission received on January 5. The entry shows a finding of substantial equivalence, product code SHW, and review by the agency's pathology panel.

What the software does

According to SimBioSys, TumorSight Risk is intended for adult women with hormone receptor-positive, HER2-negative stage I to IIIA breast cancer, a subtype the company says accounts for about 75% of US breast cancers. The cloud-based software combines breast MRI, pathology and clinical information already collected in routine care to estimate recurrence risk at five and 10 years.

It produces a score from 0 to 100 and assigns a high, intermediate or low risk category. AuntMinnie reported that, per the company, results can be available before surgery without an additional procedure or the shipping of tissue samples. TumorSight Risk builds on the company's previously cleared TumorSight Viz surgical visualization platform.

The FDA's clearance documents describe TumorSight Risk as a prescription, software-only device that combines age, race, cancer stage, nodal status and grade with dynamic contrast-enhanced MRI (DCE-MRI) data to generate five- and 10-year recurrence risks and a proprietary prognostic score. The indication covers lymph node-negative (N0) or positive (N1) disease and says the output is meant to inform a physician "in conjunction with other relevant clinicopathological factors." The documents list compatible scanners as GE and Siemens 1.5T and 3T systems.

The device was classified under 21 CFR 864.3755, the regulation for software algorithm devices that analyze digital images for cancer prognosis, and cleared as Class II. The predicate named in the summary is ArteraAI Breast (K254115).

Validation data

SimBioSys said the clearance is supported by a blinded, multi-institution validation study of 2,129 patients at Mayo Clinic, Emory University, Stanford Medicine and Mercy Medical Cedar Rapids. The company said the results were presented at the 2026 American Society of Clinical Oncology Annual Meeting.

In that study, according to the company:

  • patients classified as high risk had a 3.3-fold greater risk of recurrence than those classified as low risk;
  • each 10-point increase in the score was associated with a 22% increase in relative recurrence risk;
  • estimated five-year recurrence risk ranged from 2.2% for scores of 0 to 10 to 13.6% for scores of 58 to 100, and estimated 10-year risk ranged from 6.2% to 34.2% across the same groups;
  • the score remained significantly associated with recurrence-free survival after adjustment for standard prognostic factors (p=0.002).

These figures are company-reported. The announcement discloses that Mayo Clinic, one of the study sites, has a financial interest in SimBioSys.

"Achieving FDA clearance of TumorSight Risk marks a defining moment for SimBioSys and for precision breast cancer care," Stacey Stevens, the company's president and chief executive, said in the announcement. The release also quoted Matthew Goetz, MD, of Mayo Clinic, on the validation data.

The company did not announce pricing or a commercial launch date in the release.

Sources

  1. SimBioSys Secures FDA Clearance for TumorSight Risk, SimBioSys, October 15, 2026
  2. 510(k) Premarket Notification K260023: TumorSight Risk, US Food and Drug Administration, September 25, 2026
  3. K260023 clearance letter and 510(k) summary, US Food and Drug Administration, September 25, 2026
  4. FDA clears SimBioSys's breast cancer risk software, AuntMinnie, October 16, 2026