SimBioSys has won FDA 510(k) clearance for TumorSight Risk, an artificial-intelligence tool that scores a breast-cancer patient’s five- and ten-year recurrence risk from an MRI, pathology and clinical data already sitting in her chart — no additional scan, biopsy or tissue shipment required. The Chicago company announced the clearance on 15 October 2026; FDA’s own clearance letter for the 510(k), K260023, is dated 25 September 2026, the company’s fourth clearance on its TumorSight platform.
A score built from data already on file
TumorSight Risk is software, not a lab test: it analyzes a patient’s existing breast MRI together with pathology and clinical factors — age, cancer stage, nodal status and grade — to output a 0-to-100 score and a high-, intermediate- or low-risk classification for recurrence-free survival at five and ten years. According to SimBioSys, nothing about the workflow changes: no added procedure, no tissue sent to a separate lab, no specialized scanner. The clearance letter lists the device under product code SHW (21 CFR 864.3755), a Class II designation, with ArteraAI Breast named as the predicate.
Three things a biopsy-free score changes
No new procedure
The score is computed from an MRI, pathology report and clinical factors already in the chart — not a fresh biopsy, a tissue shipment to a reference lab, or a dedicated scanner.
Imaging, not tissue
Where today’s best-known recurrence tests read gene expression from a tumor specimen, TumorSight Risk reads the tumor’s shape and texture on imaging — a different input entirely, built on the same TumorSight platform SimBioSys has cleared three times before.
Validated across four centers
A blinded, multi-institutional study of 2,129 patients drawn from Mayo Clinic, Emory University, Stanford Medicine and Mercy Medical backs the clearance, alongside a 30-clinician human-factors study and a 99.4% agreement rate across replicate runs.
Four figures from the clearance letter
Figures from SimBioSys’ 15 October 2026 announcement and FDA’s 510(k) clearance letter, K260023.
K260023, in the FDA’s own terms
FDA’s clearance letter for K260023 describes TumorSight Risk as an artificial-intelligence, software-only device that analyzes data from previously diagnosed invasive breast-cancer patients to assess recurrence risk. The agency received the premarket notification on 5 January 2026 and issued its substantially-equivalent decision on 25 September 2026, naming ArteraAI Breast — another imaging-and-AI prognostic tool — as the predicate device rather than a tissue-based genomic assay. SimBioSys announced the clearance publicly on 15 October 2026, nearly three weeks after FDA’s own decision date, which is common: 510(k) decisions post to FDA’s database before a company times its own announcement.
“Achieving FDA clearance of TumorSight Risk marks a defining moment for SimBioSys and for precision breast cancer care.” Stacey Stevens, President and CEO, SimBioSys — 15 October 2026 announcement, as reported by Fierce Biotech
Scoring recurrence without a second biopsy
TumorSight Risk enters a category long dominated by gene-expression assays run on a tumor specimen sent to a central lab — tests such as Oncotype DX (Exact Sciences) and MammaPrint (Agendia), which clinicians already use to help decide whether a hormone receptor-positive, early-stage patient needs chemotherapy on top of endocrine therapy. SimBioSys is wagering that an MRI-based score, computed from data a patient’s care team already has, can compete for that same decision point without the added cost, turnaround time or tissue requirement a send-out genomic test carries.
The recurrence-testing shelf, sized to 2033
$259M → $576.6M
Global breast recurrence-score test market, 2024 to 2033, as forecast by Persistence Market Research.
Sources: Persistence Market Research, Breast Recurrence Score Test Market
Regulatory News outlook
We treat Persistence Market Research’s $576.6 million 2033 figure as a floor for recurrence-risk testing overall, not a ceiling on TumorSight Risk’s own opportunity: that number prices the existing tissue-based genomic-assay category alone, and TumorSight Risk is a new, non-tissue entrant competing for the same hormone receptor-positive, HER2-negative early-stage population those assays already serve.
How we got here: Persistence Market Research’s published figures ($259 million in 2024 rising to $576.6 million by 2033) cover gene-expression recurrence assays; adding an imaging-based competitor addressing the identical clinical decision, with no separate published figure of its own yet, implies the combined addressable category exceeds the genomic-only estimate rather than redividing it.
TumorSight Risk against the recurrence assays
| Product | Form | Specimen | Output | U.S. clearance |
|---|---|---|---|---|
| TumorSight Risk (SimBioSys) | AI software, reads existing MRI | None — no new biopsy or tissue | 0-100 score; high/intermediate/low risk, 5- & 10-yr | September 2026 |
| Oncotype DX (Exact Sciences) | Gene-expression assay | Tumor tissue, sent to central lab | Recurrence Score, 0-100 | 2004 (LDT; FDA-cleared components since) |
| MammaPrint (Agendia) | 70-gene expression assay | Tumor tissue, sent to central lab | Low/high risk binary result | 2007 (FDA 510(k)) |
| ArteraAI Breast | AI software, reads pathology slide image | Digitized pathology slide | Risk score and treatment-benefit estimate | Predicate for K260023 |
From each company’s own labelling and FDA clearance records; not a clinical comparison.
From an EnterpriseWorks incubator to a fourth clearance
The road from EnterpriseWorks to K260023
- 2018
SimBioSys founded
Spun out of the University of Illinois Urbana-Champaign, based initially at the campus’ EnterpriseWorks incubator.
- October 2021
$15 million Series A
Co-led by Genoa Ventures and Northpond Ventures, with AV8 Ventures, Heritage Medical Group and Mayo Clinic also participating; total capital raised reached $21 million.
- December 2023
First FDA clearance
TumorSight Viz, a 3D breast-tumor surgical-visualization platform, cleared via 510(k) K231130.
- October 2024
Second clearance
A further TumorSight Viz 510(k), K243189.
- July 2025
Third clearance
TumorSight Viz 1.3, 510(k) K251766.
- 25 September 2026
TumorSight Risk cleared
FDA’s 510(k) decision on K260023, announced by the company 15 October 2026.
What a first-of-its-kind label still has to prove
SimBioSys calls TumorSight Risk the world’s first AI-powered, MRI-derived prognostic tool for breast-cancer recurrence — a claim the company makes about itself, not one Regulatory News has independently verified against every competing imaging-based tool on the market. What is verifiable is narrower: a 510(k) clearance, a named predicate, and a 2,129-patient validation study whose full dataset has not been published in a peer-reviewed journal as of this writing.
- Coverage: ABC’s Good Morning America reported the company is working with Medicare, Medicaid and private insurers toward reimbursement; no coverage decision has been announced.
- Indication: cleared specifically for hormone receptor-positive, HER2-negative Stage I–IIIA breast cancer — it does not cover triple-negative or HER2-positive disease.
- Publication: the 2,129-patient validation study underlying the clearance has not yet appeared in a peer-reviewed journal, as far as Regulatory News can confirm.
- Adoption: SimBioSys has not announced a launch timeline, pricing, or which health systems will be first to use TumorSight Risk clinically.
Sources & further reading
- SimBioSys, announcement of FDA 510(k) clearance for TumorSight Risk, 15 October 2026, as reported by Fierce Biotech. fiercebiotech.com
- FDA, 510(k) Premarket Notification K260023 (TumorSight Risk), decision 25 September 2026. accessdata.fda.gov
- Unite.AI, “SimBioSys Earns FDA Clearance for TumorSight Risk,” 15-16 October 2026. unite.ai
- Fox television stations, “FDA clears use of AI tool designed to predict whether breast cancer will recur,” 16 October 2026. fox32chicago.com
- AuntMinnie, “FDA clears SimBioSys’s breast cancer risk software,” October 2026. auntminnie.com
- Good Morning America, “New FDA-cleared AI tool predicts breast cancer,” October 2026. goodmorningamerica.com
- Illinois Research Park / EnterpriseWorks, “EnterpriseWorks Startup SimBioSys Raises $15 Million Series A,” October 2021. researchpark.illinois.edu
- Persistence Market Research, Breast Recurrence Score Test Market, global forecast. gii.tw
Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.
Frequently asked questions
What did FDA clear for SimBioSys?
TumorSight Risk, an AI software device that analyzes breast MRI alongside pathology and clinical data to produce a 0-100 recurrence score and a high-, intermediate- or low-risk category for women with hormone receptor-positive, HER2-negative Stage I-IIIA breast cancer. The 510(k), K260023, was decided 25 September 2026 and announced 15 October 2026.
Does a patient need a new scan or biopsy?
No. SimBioSys says TumorSight Risk works from imaging, pathology and clinical data already collected as part of routine care, with no additional procedure, tissue shipment or specialized hardware.
How was it validated?
On a blinded, multi-institutional validation study of 2,129 patients from Mayo Clinic, Emory University, Stanford Medicine and Mercy Medical, plus a separate precision study (119 of 120 images processed successfully; 99.4% agreement across replicate runs) and a human-factors study with 30 physicians and clinical staff.
Is this SimBioSys's first FDA clearance?
No, its fourth. TumorSight Viz, a 3D surgical-visualization platform, was first cleared in December 2023 (K231130), cleared again in October 2024 (K243189) and as TumorSight Viz 1.3 in July 2025 (K251766). TumorSight Risk is a new, separate product built on that platform.
