The U.S. Food and Drug Administration (FDA) has approved the first artificial intelligence (AI) tool to predict breast cancer risk, developed by digital health tech company Clairity. Called Clairity Breast, the AI platform uses mammograms to generate a validated five-year risk score for women, enhancing early detection and prevention efforts. This approval marks a major advancement in personalized cancer risk assessment.
By analyzing subtle images from a screening mamm, the AI tool generates risk scores that may help healthcare providers identify women at higher risk of developing breast cancer. The platform is designed to be more equitable, addressing the limitations of traditional risk models that often rely heavily on age and family history, which fail to account for the majority of cases. The approval comes as breast cancer rates have been rising, especially among younger women, raising the need for more accurate and accessible risk assessment tools.
The approval of the Clairity Breast platform underscores the growing role of AI in healthcare, particularly in cancer detection and prevention. The tool’s potential to improve early detection and risk assessment has sparked positive responses from medical experts, including Dr. Connie Lehman, who highlighted its importance in uncovering hidden clues in mammograms, which may be invisible to the human eye. “By delivering validated, equitable risk assessments, we can help expand access to life-saving early detection and prevention for women everywhere,” she said in a press release.
Dr. Robert A. Smith, senior vice president of early cancer detection science at the American Cancer Society, also praised the platform, calling it a critical step in improving breast cancer outcomes.