Clairity Breast: FDA Approved with Support from the Breast Cancer Research Foundation

Clairity Breast is revolutionizing breast cancer care through its AI-powered platform, recently granted FDA De Novo authorization. This innovative tool predicts a woman’s five-year risk of developing breast cancer using only a standard mammogram, making it the first of its kind. Unlike current models that depend on age or family history, Clairity analyzes subtle imaging patterns, enabling personalized follow-up care before any disease signs appear. Remarkably, studies show that many women in their 40s have high-risk levels akin to older women, supporting a risk-based screening approach. The platform aims to close care gaps by ensuring representation across diverse racial and ethnic groups, making early detection accessible, especially for those without family histories of breast cancer. Scheduled for commercial launch in 2025, Clairity Breast promises to transform mammograms from diagnostic tools into predictive assessments, enhancing early detection and empowering women to take charge of their health.

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