Clairity Becomes the First FDA-Authorized AI Platform for Breast Cancer Prediction – Historic Milestone for Women’s Health

CLAIRITY BREAST provides clinicians with a first-in-class, novel platform for identifying future risk of breast cancer

A milestone in equitable healthcare, with potentially life-saving insights from a screening mammogram alone

FDA grants De Novo authorization for new device for future five-year breast cancer risk prediction, based on an image alone

BOSTON & CHICAGO–(BUSINESS WIRE)–June 2, 2025–

Clairity, Inc., a digital health innovator advancing AI-driven healthcare solutions, has received U.S. Food and Drug Administration (FDA) De Novo authorization for CLAIRITY BREAST, a novel, image-based prognostic platform designed to predict five-year breast cancer risk from a routine screening mammogram. With this authorization, Clairity is planning to launch among leading health systems through 2025 – propelling a new era of precision medicine in breast cancer.