A New Look at Breast Cancer Risk

Clairity's FDA De Novo authorized imaging AI advances early risk prediction as health systems explore modernized screening

21 Nov 2025

US regulators have approved the first artificial intelligence system that estimates a woman’s five-year breast cancer risk using data from a routine mammogram, marking a significant step in the use of predictive imaging in preventive care. The decision, issued through the Food and Drug Administration’s De Novo pathway, is seen by clinicians as an early sign that screening strategies may shift toward more data-driven assessment.

The system, Clairity, analyses patterns within breast tissue that may be difficult for radiologists to detect. It generates risk estimates without relying on genetic screening or family history, a feature that has attracted interest from large hospital networks seeking more precise ways to identify patients who may benefit from earlier or more frequent imaging.

The approval comes as health systems scale up their use of AI intended to support clinical decisions. Imaging groups such as ScreenPoint Medical have broadened their portfolios as hospitals look for tools that ease pressure on radiology teams and improve accuracy. Analysts say the sector is entering a period of faster expansion, driven by innovation and an increase in commercial partnerships.

A wider rollout could alter long-established screening habits. Providers may shift from uniform schedules to plans shaped by individual risk, while patients could gain earlier insight into potential disease. Insurers are also expected to examine how more targeted screening might influence coverage policies and long-term costs.

Clinicians have nevertheless urged caution. They call for clear communication around risk scores and stress the need for extensive testing across different demographic groups. A senior leader at CommonSpirit recently noted that strong standards are essential to prevent confusion. Industry advisers argue that such safeguards will be critical as predictive tools become more common in routine care.

For now, momentum behind the technology is growing. The move from theoretical modelling to practical deployment is prompting hospitals, investors and researchers to reconsider the role predictive imaging could play in future cancer prevention strategies.