
Clairity Breast becomes the first FDA-authorized AI software to predict five-year breast cancer risk using routine mammography images.
Key Details
- 1FDA grants de novo authorization to Clairity Breast, developed by Boston-based Clairity.
- 2The AI tool analyzes mammogram images for subtle features correlated with future cancer risk.
- 3Unlike traditional models, Clairity Breast does not require age or genetic data.
- 4The system was trained on millions of mammogram images linked to five-year outcomes.
- 5Clairity Breast delivers validated risk scores to radiologists through standard clinical systems.
- 6Commercial launch is targeted for the end of 2025.
Why It Matters
This breakthrough FDA authorization marks a new era in preventive oncology by enabling earlier risk identification using only imaging, potentially improving precision prevention and patient outcomes in breast cancer care.

Source
Radiology Business
Related News

•AI in Healthcare
FDA Seeks Real-World Performance Insights on AI Medical Devices
FDA calls for healthcare worker feedback to enhance monitoring of AI-enabled medical devices in real-world settings.

•Radiology Business
Aidoc Receives FDA Breakthrough Status for Multi-Condition CT AI Triage
Aidoc has received FDA Breakthrough Device status for its AI solution that flags multiple critical conditions in CT scans.

•Cardiovascular Business
AI Uses Mammograms to Predict Women’s Cardiovascular Disease Risk
AI algorithms can analyze mammograms to predict cardiovascular disease risk, expanding the utility of breast imaging.