Clairity’s AI wins FDA nod for breast cancer risk prediction

USA – Clairity, a healthcare technology company, has received FDA De Novo authorization for its AI-powered tool CLAIRITY BREAST, which predicts a woman’s five-year risk of developing breast cancer using just a standard mammogram.

The company plans to begin rolling out the platform across top U.S. health systems throughout 2025.

CLAIRITY BREAST uses advanced image analysis to detect subtle features in mammogram images –features that may go unnoticed by the human eye.

These patterns can signal future cancer risk, allowing doctors to identify higher-risk patients early and tailor follow-up care accordingly.

Instead of relying on questionnaires or genetic tests, this AI platform generates a validated risk score from the screening image alone.

The result is shared with healthcare providers through their existing clinical systems, helping them decide which patients might benefit from closer monitoring or additional tests, such as MRIs.

Dr. Connie Lehman, founder of Clairity and a breast imaging expert at Mass General Brigham, emphasized the value of combining AI with traditional screening.

“Mammograms have long been vital for early cancer detection. With AI, we can now find hidden clues in these images that reveal a woman’s future cancer risk,” he said.

Experts in cancer prevention agree that tools like CLAIRITY BREAST could change how breast cancer is screened and managed.

According to Dr. Robert A. Smith from the American Cancer Society, personalized screening based on individual risk is the future of breast cancer care.

“AI models can help us find women who are more likely to develop cancer, so we can act sooner and more effectively,” he noted.

The FDA’s approval makes CLAIRITY BREAST the first platform of its kind in the US$ 63 billion global breast cancer prediction market.

Its arrival signals a move toward more personalized, risk-based screening – a shift that could improve early detection and prevention for millions of women worldwide.