Clairity, Inc., a digital health innovator focused on AI-powered healthcare solutions, has received De Novo authorization from the U.S. Food and Drug Administration (FDA) for its CLAIRITY BREAST platform. This breakthrough image-based prognostic tool predicts five-year breast cancer risk using routine mammogram screenings. Clairity plans to launch the product within leading health systems by 2025, ushering in a new era of precision medicine for breast cancer.
Addressing a Critical Need in Breast Cancer Detection
Breast cancer remains a global health challenge, with over 2.3 million new cases diagnosed annually worldwide, including more than 370,000 women in the U.S. Early detection and risk assessment are key to saving lives. However, current risk models mostly depend on age and family history—yet 85% of women diagnosed have no family history, and nearly half have no identifiable risk factors. Furthermore, many traditional models rely on data from white European populations and often fail to accurately predict risk for women of diverse racial and ethnic backgrounds.
How CLAIRITY BREAST Works
CLAIRITY BREAST analyzes subtle imaging features in routine screening mammograms that correlate with future breast cancer risk. By generating a validated five-year risk score directly from mammogram images, the platform enables personalized follow-up care without additional tests. The risk scores are integrated into existing clinical workflows, empowering healthcare providers to make more precise, individualized care decisions.
Expert Endorsements Highlight Potential Impact
Dr. Robert A. Smith, Senior Vice President of Science for Early Cancer Detection at the American Cancer Society, emphasized the importance of AI-driven personalized screening:
“Personalized, risk-based screening is critical to improving breast cancer outcomes, and AI tools provide us with the best opportunity to realize this potential.”
Larry Norton, Founding Scientific Director of the Breast Cancer Research Foundation, noted:
“Clairity’s FDA authorization is a turning point for more women, giving them access to AI-driven scientific advances in cancer risk prediction.”
A Transformative Step Forward in Breast Cancer Care
Jeff Luber, CEO of Clairity, described the launch as a landmark innovation:
“We can now predict future cancer risk from patterns in breast tissue during routine screening—before cancer is present. Our platform integrates seamlessly into clinical settings to scale precision prevention, ultimately reducing late diagnoses, lowering costs, and saving lives.”
Setting a New Standard in Breast Cancer Prediction
The FDA’s De Novo authorization recognizes CLAIRITY BREAST as a best-in-class product in the growing $63 billion global breast cancer prediction market. It sets a new benchmark for personalized, risk-based screening and proactive cancer prevention strategies.
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