AI Breast Cancer Risk Prediction Tool Gains FDA Approval
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The FDA has cleared an AI tool designed to predict breast cancer risk, offering faster insights that could transform oncology practices. This development signals significant investment opportunities and competitive shifts in the pharmaceutical landscape.
Oncology teams watching AI breast cancer risk tools should start with Clairity's FDA De Novo, not a fictional NCHStats clearance. On May 30, 2025, FDA authorized Allix5 (DEN240047) to output a five-year risk score from screening mammograms under new Class II product code SEZ.
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Key Takeaways
- FDA authorized Clairity Allix5 on May 30, 2025 via De Novo DEN240047 as Class II radiological software for 5-year breast cancer risk prediction.
- The order created regulation 21 CFR 892.8500 and product code SEZ for this device type.
- Allix5 analyzes bilateral screening mammograms and is not intended to diagnose, detect, or solely drive treatment decisions.
- A separate March 3, 2026 PMA (P250008) cleared Perimeter's Claire OCT System for adjunctive AI marking of suspicious focal areas in lumpectomy tissue.
What did FDA authorize for Clairity Allix5?
FDA's May 30, 2025 De Novo order for DEN240047 classifies Clairity, Inc.'s Allix5 as a prescription Class II device. The indicated use is a five-year breast cancer risk prediction based on a bilateral screening mammogram.
According to the FDA DEN240047 order PDF, Allix5 outputs a percentage probability that the individual will be diagnosed with or develop breast cancer within five years after the screening exam, through analysis of mammography features.
Eligible patients do not have known breast cancer at presentation. The output is intended to be considered after the radiologist finishes interpreting the screening mammogram.
How does product code SEZ change the oncology AI map?
FDA created the generic type "radiological software device to predict future breast cancer risk" under 21 CFR 892.8500 with product code SEZ. Future similar tools can pursue 510(k) pathways against that classification.
FDA's public AI/ML-enabled medical devices list records Allix5 (Clairity, Inc.) under radiology product code SEZ with a May 30, 2025 decision date tied to DEN240047.
That listing is the allowlisted chronology sponsors should cite instead of secondary blogs that invent vendors such as "NCHStats."
What limits did FDA put on clinical use?
The order states Allix5 is not intended to diagnose or detect breast cancer, provide care recommendations, or replace clinical judgment as the sole decision factor. It also is not intended to guide interpretation of the imaging exam itself.
Input scope is limited: Allix5 analyzes full-field digital mammograms or directly acquired 2D images from specified Hologic Lorad Selenia and Selenia Dimensions systems and does not analyze synthetic-2D images.
For pharma oncology teams, the practical implication is risk stratification adjacency to screening workflows, not a substitute for biopsy, staging, or drug-selection algorithms.
How does the Claire OCT PMA differ?
On March 3, 2026, FDA approved PMA P250008 for Perimeter Medical Imaging's Claire OCT System, an adjunctive three-dimensional imaging tool with an AI computer-aided detection algorithm for marking focal areas suspicious for breast cancer in excised lumpectomy tissue.
That PMA cites clinical trial NCT05113927 and is an intraoperative margin-aid device, not a five-year population risk score from screening mammography.
Keep Clairity risk prediction and Claire surgical OCT in separate diligence buckets when modeling oncology pathway disruption.
What should BD and investor teams watch next?
Watch health-system adoption of SEZ-class risk scores, payer coverage for AI risk reporting, and whether subsequent 510(k) entrants crowd Clairity's first-in-class De Novo position.
Also watch whether risk outputs change supplemental imaging utilization in ways that affect screening-interval drug prevention trials. Pair device news with NovaPharma's May 2026 drug approvals roundup and Bizengri rare oncology priority case.
Related NovaPharma coverage
- May 2026 FDA drug approvals regulatory roundup
- Bizengri FDA priority for rare bile duct cancer
- Manufacturing pipeline approvals evidence brief
Frequently Asked Questions
What AI breast cancer risk tool did FDA authorize?
On May 30, 2025, FDA issued De Novo classification DEN240047 for Clairity Allix5, a radiological software device that generates a 5-year breast cancer risk prediction from a bilateral screening mammogram.
What is product code SEZ?
SEZ is the Class II product code FDA created for radiological software devices that predict future breast cancer risk from breast imaging under 21 CFR 892.8500.
Is Allix5 meant to diagnose breast cancer?
No. FDA's order states Allix5 is not intended to diagnose or detect breast cancer, provide care recommendations, or serve as the sole determinant for clinical decision-making.
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