FDA approves AI for 5-year breast cancer risk prediction

The FDA has granted de novo authorization to Clairity's AI platform, CLAIRITY BREAST, marking a milestone in using AI for breast cancer risk prediction solely through routine mammograms.

Why it matters: 

This AI tool fills a significant gap in traditional risk models, which often overlook 85% of breast cancer cases lacking family history.

• Clairity's AI dives deep into mammogram pixels to detect subtle patterns, predicting cancer risk up to five years ahead.

Validation success: 

Clairity's platform, trained on millions of images, was validated with over 77,000 mammograms from five diverse centers, ensuring broad applicability.

• It provides personalized risk scores that seamlessly integrate into current clinical workflows, enabling tailored follow-up care.

Background: 

Traditional models rely heavily on age and family history, but Clairity's approach offers a more inclusive assessment, catering to diverse population needs.

What they're saying: 

"Advancements in AI can uncover hidden clues in mammograms to help predict future risk," noted Connie Lehman, Clairity's founder.

Looking ahead: 

Founded in 2020 with backing from Santé Ventures and ACE Global Equity, Clairity plans to introduce its platform across major health systems by 2025, potentially transforming patient care and risk assessment.

The bottom line: 

This AI tool not only enhances early detection but also paves the way for more personalized and effective breast cancer prevention strategies.