The U.S. Food and Drug Administration (FDA) has approved the first artificial intelligence (AI) tool designed to predict breast cancer risk. The platform, Clairity Breast, developed by digital health company Clairity, uses routine mammogram images to assess a woman’s five-year breast cancer risk.
Clairity plans to launch this AI tool across health systems by 2025. Traditional risk assessment models for breast cancer mainly rely on age and family history, but Clairity points out that about 85% of breast cancer cases occur in women with no family history. Additionally, many traditional models were based on data from predominantly European Caucasian women, making them less applicable to diverse populations.
The AI tool analyzes subtle features in mammogram images that are linked to breast cancer risk and generates a “validated five-year risk score” for healthcare providers.
Dr. Connie Lehman, founder of Clairity and breast imaging expert at Mass General Brigham, emphasized the importance of AI in detecting hidden signs of cancer. “Advancements in AI can uncover clues in mammograms that are invisible to the human eye,” she said. “By offering equitable risk assessments, we aim to improve access to early detection and prevention.”
Dr. Robert A. Smith from the American Cancer Society called personalized, risk-based screening “critical to improving breast cancer outcomes,” adding that AI tools offer the best opportunity for achieving this.
Larry Norton, founding scientific director of the Breast Cancer Research Foundation, described Clairity’s FDA approval as a major step forward. “Breast cancer is on the rise, especially among younger women, and current risk models often miss those at risk,” he said.
Globally, over 2.3 million women are diagnosed with breast cancer annually, including 370,000 in the U.S. The disease is particularly increasing among women under 50.
Fox News senior medical analyst Dr. Marc Siegel praised the AI development as “profound,” noting that AI significantly improves mammogram accuracy. He also highlighted its potential for underserved areas where radiologists may lack specialized training.
While Siegel acknowledged AI’s growing role, he stressed that it will complement, not replace, human expertise in cancer detection.
Related topics:
