Cancer · Prediction and risk
AI that predicts five-year breast cancer risk from a mammogram
In May 2025 the US FDA granted Clairity's De Novo request for Allix5: software that estimates a woman's chance of breast cancer in the next five years from a routine screening mammogram. It's authorised in the US only. It gives a prediction, not a diagnosis.
How far away is this?
FDA 'granted' a De Novo request, which is an authorisation to market in the US. The rating applies to the US only and reflects authorisation; we haven't confirmed how widely it is used with patients. Note the wording: De Novo 'granted' is not the same as 'approved'.
Where is it approved?
| Region | Regulator | Status | Notes |
|---|---|---|---|
| United States | FDA | FDA De Novo request granted, 30 May 2025 (prescription use).[1] | |
| European Union | CE mark / EMA | Unknown | |
| United Kingdom | MHRA | Unknown | |
| Australia | TGA | Unknown |
Authorised in the US. We haven't found records for other regions, so they're marked Unknown. "Unknown" means we haven't verified it, not that it's unavailable. Approval in one country isn't approval in another.
What is it?
Most breast cancer risk tools use age and family history. This one looks at patterns in the mammogram image itself and gives a percentage risk for the next five years, after a radiologist has read the scan.
What's the evidence?
FDA granted the De Novo request for Allix5 (Clairity, Inc.) on 30 May 2025, creating a new device type: 'radiological software device to predict future breast cancer risk'.[1]
Evidence stage: Approved & in use · #c1
It gives a 5-year risk estimate from a standard screening mammogram. It is not intended to diagnose or detect cancer, give care recommendations, or be the sole basis for decisions.[2]
Evidence stage: Approved & in use · #c2
It's a prescription device, and only works with images from certain Hologic mammography machines (not synthetic 2D images).[2]
Evidence stage: Approved & in use · #c3
FDA's decision summary describes a retrospective study at five US sites (77,511 exams from 44,112 patients). Accuracy at predicting cancer within five years (AUC) was 0.70 overall, and 0.66 when women whose cancer was already present were excluded (1.0 would be perfect; 0.5 is chance). FDA notes its predictions weren't shown to be well calibrated for women with breast implants, Asian women, or women under 50 or over 65.[3]
Evidence stage: Approved & in use · #c4
What does it mean for me?
Outside the US, this isn't something you can ask for today as far as we know. A risk score is a prediction, not a diagnosis. A 'high risk' result may lead to extra imaging such as MRI, which can bring false alarms and worry. Risk tools can also work less well in groups that were under-represented when they were tested. Your doctor can talk through your own breast cancer risk using existing tools.
What could I ask my doctor?
- What is my breast cancer risk, and how was it worked out?
- Would knowing my risk change how often I'm screened?
- Are any image-based risk tools available here?
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.
Change history
- : First published.
- : Updated after independent fact-check and clinical review
- : Review label corrected: this page was not clinically reviewed. Earlier labels saying 'independent fact-check' and 'clinical review' were wrong; checks so far were AI-assisted source checks only.
General information only, not medical advice. Talk to your doctor about your situation. AI-assisted source check. Not clinically reviewed.
References
- FDA De Novo database: DEN240047 (Allix5). accessdata.fda.gov. Regulator. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240047
- FDA De Novo grant letter (PDF). accessdata.fda.gov. Regulator. https://www.accessdata.fda.gov/cdrh_docs/pdf24/DEN240047.pdf
- FDA decision summary (PDF). accessdata.fda.gov. Regulator. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN240047.pdf
Publisher shown as the website hosting each source. Dates are given where the source label includes them.