Cancer · Prediction and risk
The FDA clears an AI that estimates whether breast cancer will come back, using MRI scans
TumorSight Risk, from SimBioSys, got US FDA clearance on 25 September 2026. It combines a breast MRI with facts like age and tumour grade to give a 5- and 10-year chance of the cancer returning. The FDA's summary reports a study of 2,129 past patients at 4 US sites: within 5 years, 3.0% of those it rated low risk had the cancer come back, against 9.8% of those rated high risk (8.6% vs 26.4% within 10 years). That study used past records and isn't published in a journal, and we haven't confirmed the tool is in use. Rating: Early research.
How far away is this?
Cleared in the US (510(k), Class II). The FDA's summary reports a study of past patient records, not a trial in current care or a journal paper, and we haven't confirmed it's in use, so it's Early research, the level we give studies of past records.
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Where is it approved?
| Region | Regulator | Status | Notes |
|---|---|---|---|
| United States | FDA | Cleared | FDA 510(k) clearance, 25 September 2026. FDA 510(k) K260023[1] |
| European Union | CE mark / EMA | Unknown | Register not searched yet. |
| United Kingdom | MHRA | Unknown | Register not searched yet. |
| Australia | TGA | Unknown | Register not searched yet. |
Cleared in the US only, as far as we've checked. "Register not searched yet" means we haven't searched that regulator's register; it doesn't mean the product is or isn't available. Approval in one country isn't approval in another.
What is it?
After an early breast cancer diagnosis, doctors weigh how likely it is to come back when choosing treatment. This software looks at a special contrast MRI scan along with age, race, stage, lymph node status and grade, and gives a risk score. It's for doctors, on prescription, to use alongside other information.
What's the evidence?
FDA 510(k) K260023: TumorSight Risk by SimBioSys, Inc. was received on 5 January 2026 and found substantially equivalent (cleared) on 25 September 2026, as a Class II device.[1]
Evidence stage: Early research · #c1
It's cleared for adult women with hormone receptor positive, HER2 negative, stage I to IIIA invasive breast cancer, that is node negative or node positive at N1 stage. It gives 5- and 10-year recurrence risks to inform a doctor, not to decide alone.[2]
Evidence stage: Early research · #c2
The FDA's 510(k) summary reports a retrospective study of 2,129 patients diagnosed between 2010 and 2024 at 4 US sites. The cancer came back within 5 years in 3.0% of low-risk, 5.7% of intermediate-risk and 9.8% of high-risk patients (8.6%, 13.4% and 26.4% within 10 years). We found no journal publication of this study.[2]
Evidence stage: Early research · #c3
What does it mean for me?
If you've had HR-positive, HER2-negative early breast cancer in the US, your team might one day show you a TumorSight score. Ask how it changes your treatment plan and what evidence backs it. It's meant to sit beside your other test results, not replace them.
What could I ask my doctor?
- How would a recurrence score change my treatment options?
- What evidence shows this score is accurate for someone like me?
These are general starting points, not a recommendation to choose any particular test or treatment.
If you're worried about your health right now, contact your doctor or local health advice line. In an emergency, contact your local emergency number.
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Change history
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General information only, not medical advice. Talk to your doctor about your situation. AI-assisted source check. Not clinically reviewed.
References
- FDA 510(k) database: K260023 (TumorSight Risk). accessdata.fda.gov. Regulator. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260023
- FDA clearance letter, indications for use and 510(k) summary: K260023. accessdata.fda.gov. Regulator. https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260023.pdf
Publisher shown as the website hosting each source. Dates are given where the source label includes them.