Clairity, a digital health innovator focused on AI-powered healthcare solutions, has announced U.S. Food and Drug Administration (FDA) De Novo authorization for its breakthrough platform, CLAIRITY BREAST. This novel, image-based prognostic tool is designed to predict a woman’s five-year breast cancer risk using data from a routine screening mammogram. With this milestone, Clairity plans to roll out its platform across leading U.S. health systems through 2025, advancing a new era in precision medicine for breast cancer.
Each year, over 2.3 million women worldwide are diagnosed with breast cancer, including more than 370,000 in the U.S. alone. While mammography remains a cornerstone for early detection, traditional risk assessment tools often fall short—relying primarily on age and family history. However, 85% of women diagnosed with breast cancer have no family history, and many have no known risk factors. Moreover, existing models have limited accuracy for racially and ethnically diverse populations.
CLAIRITY BREAST uses advanced AI and computer vision to analyze subtle imaging features on standard mammograms that may correlate with future cancer risk—patterns often undetectable to the human eye. The result is a validated five-year risk score, integrated into existing clinical workflows, enabling healthcare providers to offer personalized screening and prevention plans.
“Our platform moves beyond cancer detection to predicting future risk from routine mammograms,” said Dr. Connie Lehman, Founder of Clairity and breast imaging specialist at Mass General Brigham. “This empowers equitable, data-driven prevention for women, regardless of background.”
Dr. Robert A. Smith of the American Cancer Society emphasized, “AI tools like CLAIRITY BREAST are vital for tailoring screening approaches and identifying those who may benefit from additional imaging such as MRI.”
Jeff Luber, CEO of Clairity, added, “This FDA authorization is a turning point. By recognizing patterns in otherwise normal mammograms, CLAIRITY BREAST allows clinicians to act before disease appears—scaling precision prevention, improving outcomes, and reducing costs.”
Positioned within the $63 billion global breast cancer prediction market, CLAIRITY BREAST sets a new benchmark for personalized, risk-based cancer prevention, offering earlier and more accurate interventions for women everywhere.