Clairity has received FDA De Novo authorization for CLAIRITY BREAST, the first AI platform authorized to predict five-year breast cancer risk from routine screening mammograms, marking a historic milestone for women’s health and precision medicine.
The authorization addresses critical gaps in breast cancer risk assessment, particularly for diverse populations. Traditional risk models, built primarily on data from European Caucasian women, have not generalized well to women of diverse racial and ethnic backgrounds. Additionally, 85% of women diagnosed with breast cancer have no family history, and nearly half have no identifiable risk factors.
“For more than 60 years, mammograms have saved lives by detecting early-stage cancers. Now, advancements in AI and computer vision can uncover hidden clues in the mammograms – invisible to the human eye – to help predict future risk,” said Dr. Connie Lehman, Founder of Clairity and breast imaging specialist at Mass General Brigham. “By delivering validated, equitable risk assessments, we can help expand access to life-saving early detection and prevention for women everywhere.”
CLAIRITY BREAST analyzes subtle imaging features on screening mammograms that correlate with future breast cancer risk, providing healthcare providers with validated five-year risk scores through existing clinical infrastructure. The AI model was trained on millions of images and validated across more than 77,000 mammograms from five geographically distinct screening centers serving diverse patient populations.
“Personalized, risk-based screening is critical to improving breast cancer outcomes, and AI tools offer us the best opportunity to fulfill that potential,” said Dr. Robert A. Smith, Senior Vice President of Early Cancer Detection Science at the American Cancer Society. “By integrating AI models that assess individual risk, we can better identify women at higher risk, and those who may benefit from supplemental screening methods, such as MRI.”
The technology addresses a significant health challenge, with over 370,000 women diagnosed with breast cancer annually in the United States and 2.3 million cases worldwide. Larry Norton, Founding Scientific Director of the Breast Cancer Research Foundation, noted that breast cancer rates are rising, especially among younger women.
“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,” said Jeff Luber, CEO of Clairity.
Founded in 2020 by Dr. Lehman and backed by Santé Ventures and ACE Global Equity, Clairity plans to launch among leading health systems through 2025.
