FDA Clears Revolutionary AI Tool for Early Breast Cancer Risk Prediction
Summary
The FDA has granted De Novo authorization to Clairity Breast, the first AI-powered platform that predicts a woman's risk of developing breast cancer over the next five years using only a standard mammogram, paving the way for more personalized and equitable breast cancer prevention and care.
Key Points
- The FDA has granted De Novo authorization to Clairity Breast, the first AI-powered platform that predicts a woman's risk of developing breast cancer over the next five years using only a standard mammogram.
- Clairity Breast analyzes the mammogram itself, using advanced AI to detect subtle patterns in breast tissue that correlate with future cancer development, even if the mammogram appears normal.
- Clairity Breast has the potential to improve early detection, expand access to personalized care, and reduce disparities in breast cancer screening and prevention.