Clairity, Inc., founded in 2020 in Boston, has developed an innovative AI-driven platform called CLAIRITY BREAST, which recently received FDA De Novo authorization.

This platform predicts five-year breast cancer risk based on routine screening mammograms, analyzing subtle imaging features to deliver a validated risk score.

The AI model behind CLAIRITY BREAST was trained on millions of images and validated with over 77,000 mammograms from diverse populations, ensuring its broad applicability.

In studies leading to FDA authorization, CLAIRITY BREAST detected 8.6 cancers per 1,000 patients, significantly outperforming traditional risk models.

Traditional risk assessment models often rely on age and family history, which are inadequate since 85% of breast cancer cases occur in women with no family history.

Larry Norton from the Breast Cancer Research Foundation emphasized the platform's potential to provide timely care to women at risk, particularly as breast cancer rates rise among younger demographics.

Experts believe that personalized, risk-based screening using AI can significantly improve breast cancer outcomes and prevention strategies.

The platform is designed to integrate seamlessly into existing clinical workflows, promoting proactive cancer prevention strategies and equitable healthcare.

Clairity plans to launch this technology in leading health systems throughout 2025, marking a significant advancement in precision medicine for breast cancer.

By producing a validated risk score, CLAIRITY BREAST aims to guide personalized follow-up care, potentially improving outcomes for women, especially those in their 40s.

The AI system aims to provide immediate insights that can inform decisions on additional imaging, such as breast MRI, enhancing early detection efforts.

The American Cancer Society encourages women to discuss risk-based screening with their healthcare providers and advocate for access to this innovative tool.