Boston & Chicago – In a historic move for women’s health, the U.S. Food and Drug Administration has granted De Novo authorization to Clairity, Inc. for its AI-powered platform, CLAIRITY BREAST. The platform becomes the first FDA-authorized artificial intelligence tool designed to predict a woman’s five-year risk of developing breast cancer using a standard screening mammogram alone.
CLAIRITY BREAST analyzes subtle imaging patterns that are invisible to the human eye, offering a validated risk score without requiring additional tests, family history, or genetic information. The technology is designed to integrate seamlessly into current clinical workflows, supporting early intervention and more personalized care strategies.
“This is a sea change in breast cancer prevention,” said Dr. Connie Lehman, Clairity founder and breast imaging specialist at Mass General Brigham. “For over 60 years, mammograms have helped detect existing cancers. Now, AI can identify hidden signs that predict a future risk—potentially years before cancer appears.”
The platform addresses longstanding gaps in breast cancer risk assessment. Traditional models often rely on age and family history, missing up to 85% of women who are eventually diagnosed with the disease and have no family history. Moreover, those models are typically based on data from predominantly white populations, limiting their effectiveness across diverse racial and ethnic groups.
By delivering risk assessments through routine mammograms, CLAIRITY BREAST could expand access to early detection and supplemental screening methods such as MRIs for women at elevated risk. Experts say this approach has the potential to reduce late-stage diagnoses and lower treatment costs.
“AI tools like CLAIRITY BREAST are critical to enabling personalized screening,” said Dr. Robert A. Smith of the American Cancer Society. “They help identify who might benefit from more intensive screening and prevention.”
Jeff Luber, CEO of Clairity, emphasized the platform’s ability to scale across health systems. “Our goal is to help providers implement precision prevention on a broad level—predicting risk even when mammograms appear normal.”
Industry leaders view the FDA’s authorization as a milestone in the $63 billion global breast cancer prediction market and a leap forward in equitable care. Clairity plans to roll out the platform across leading U.S. health systems throughout 2025.
