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 office

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