Key points from article :
The FDA’s De Novo authorization on June 2, 2025, for Clairity Breast marks a pivotal moment in breast cancer care: for the first time, a routine mammogram can be analysed by AI to forecast a woman’s five-year risk of developing breast cancer, not just detect existing disease. Trained on millions of mammogram images with outcome data and validated across diverse populations, this AI tool discerns subtle tissue patterns invisible to the human eye and delivers a personalized risk score through existing clinical systems.
Traditional risk models, which depend on age, family history, and self-reported factors, often miss 85% of breast cancer cases that occur in women without a known genetic predisposition. In a study involving over 30,000 mammograms, Clairity found that 37% of women in their 40s were at intermediate risk and 16% at high risk—risk levels comparable to those seen in older age groups—suggesting that age-based screening guidelines may leave many at-risk women undetected.
Importantly, Clairity Breast aims to reduce healthcare disparities by relying solely on standard 2D mammograms rather than demographic or genetic information and by being trained on a racially and ethnically diverse dataset. This makes it more accessible and equitable, particularly for women in underserved communities or those without access to advanced imaging or family-history-based models.
By flagging high-risk individuals, the tool enables personalized interventions such as MRI screening, lifestyle changes, genetic counselling, and preventive medications, while low-risk women may avoid unnecessary follow-ups and anxiety. With a planned commercial launch in late 2025 and efforts underway to secure insurance coverage, this AI-driven risk assessment could transform mammography from a reactive diagnostic procedure into a proactive prevention strategy—catching cancer before it takes hold and improving outcomes while reducing costs.
