FDA Authorizes First AI Platform for Breast Cancer Prediction

FRIDAY, June 6, 2025 (HealthDay News) — The U.S. Food and Drug Administration has granted de novo authorization to CLAIRITY BREAST, a first-in-class, image-based platform that can help predict a woman”s risk for breast cancer.

CLAIRITY BREAST is designed as a prognostic tool that can predict the five-year risk for developing breast cancer by analyzing subtle imaging features on routine mammograms, making early risk prediction possible. A validated five-year risk score is then delivered to health care providers through their current clinical systems.

“What makes the availability of CLAIRITY BREAST a true sea change is that we”re now predicting risk of future cancer from patterns in breast tissue, in an otherwise normal screening, before it”s even there,” Jeff Luber, chief executive officer of Clairity, said in a statement. “CLAIRITY BREAST is designed to fit seamlessly into the current clinical infrastructure.”

The AI model powering CLAIRITY BREAST has undergone extensive training using millions of images. Its performance has been validated across a dataset of more than 77,000 mammograms sourced from five geographically diverse screening centers. These centers include hospital-based and free-standing facilities, collectively serving a broad and diverse patient population. Importantly, this validation is anchored in comprehensive five-year outcome data.

“Personalized, risk-based screening is critical to improving breast cancer outcomes, and AI tools offer us the best opportunity to fulfill that potential,” Robert A. Smith, M.D., senior vice president of early cancer detection science at the American Cancer Society, said in a statement. “By integrating AI models that assess individual risk, we can better identify women at higher risk, and those who may benefit from supplemental screening methods, such as MRI, improving early detection and more effective prevention strategies.”

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