Clairity has received FDA De Novo authorization for CLAIRITY BREAST, an 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.
CLAIRITY BREAST analyzes subtle imaging features on screening mammograms that correlate with future breast cancer risk, making early risk prediction feasible based on a screening mammogram alone. The result is a validated five-year risk score delivered to healthcare providers through existing clinical infrastructures, supporting more personalized follow up care.
“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, who is also a 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.”
“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, improving early detection and more effective prevention strategies.”
The FDA De Novo authorization positions CLAIRITY BREAST as a first-in-class platform within the $63 billion global breast cancer prediction market, ushering in a new standard for personalized, risk-based screening and cancer prevention.
