A technology that harnesses artificial intelligence (AI) to analyze mammograms and improve the accuracy of predicting a woman’s personalized 5-year risk of developing breast cancer has received Breakthrough Device designation from the FDA. Developed by researchers at Washington University (WashU) School of Medicine in St. Louis, the software has been licensed to Prognosia Inc, a startup company based at WashU School of Medicine.1
The system analyzes mammograms to produce a risk score estimating the likelihood that a woman will develop breast cancer over the next 5 years. The technology is compatible with both types of mammogram imaging available: the 4 two-dimensional views of the breast produced by full-field digital mammography and the synthetic three-dimensional view of the breast produced by digital breast tomosynthesis. Importantly, the system produces an absolute 5-year risk, which makes it possible to compare a woman’s risk to an average risk based on national breast cancer incidence rates. This provides a meaningful estimate that is aligned with the US national risk reduction guidelines, so that clinicians will know what steps to take next if a woman’s risk is elevated.
The FDA Breakthrough Device designation provides an expedited review process for full market approval to give patients and clinicians accelerated access to new medical devices.
The software package, called Prognosia Breast, is a pretrained machine learning system that analyzes mammogram images and provides an estimate of how likely a patient is to develop breast cancer over the next 5 years, based solely on images and a woman’s age. According to the developers, Prognosia Breast’s estimations are 2.2 times more accurate than the standard method, which is based on questionnaires that consider factors such as age, race, and family history. The system was trained on past mammograms from individuals who underwent breast cancer screening through Siteman Cancer Center. Some of them went on to develop cancer, teaching the system what to look for in the earliest stages of tumor development. Such early signs of disease cannot be perceived even by a well-trained human eye.
The new device could have a large impact on risk prediction because the infrastructure is already in place to begin using the software immediately anywhere mammography is provided. Furthermore, many women already receive regular mammograms. According to 2023 survey data from the Centers for Disease Control and Prevention, >75% of women aged 50 to 74 years reported having received a mammogram in the past 2 years.
Even with widespread screening, approximately 34% of breast cancer patients in the United States are diagnosed at later stages of the disease. According to the investigators, being able to assess risk up to 5 years in advance of the onset of cancer is likely to improve early detection, reducing the number of late-stage cancers diagnosed. Early detection has been shown to make treatment more effective and reduce deaths from breast cancer.
“Receiving a Breakthrough Device designation is a powerful validation of the extraordinary dedication and vision of this research team to improve breast cancer diagnosis and care,” Doug E. Frantz, PhD, vice chancellor for Innovation and Commercialization at WashU, said in a prepared statement on the designation. “It takes years of concerted effort to produce software that could quickly be integrated into the workflow of any mammography center, significantly enhancing the clinical value of routine mammograms no matter where they are provided. This is a prime example of the vital role of entrepreneurship and commercialization at WashU in transforming cutting-edge research into real-world technologies that improve patient care.”
The device produces a 5-year risk score that is intended to complement, not replace, the analysis provided by radiologists, who will continue to review the mammograms following standard protocols. According to ASCO and the US Preventive Services Task Force, a 5-year risk score of ≥3% is considered elevated. According to guidelines from these organizations, women with elevated scores should be referred to specialists who can further advise them on their options for additional screening and prevention strategies.
Approximately 1 in 8 women in the United States will be diagnosed with breast cancer in their lifetime.
The current FDA designation applies to the software’s analysis of mammogram images taken at a single time point. In the future, the researchers plan to update Prognosia Breast to analyze several years of mammograms from the same individual, which may further improve the accuracy of the prediction.
Reference
- WashU Medicine. AI-based breast cancer risk technology receives FDA Breakthrough Device designation [news release]. July 29, 2025. Accessed August 12, 2025. https://medicine.washu.edu/news/ai-based-breast-cancer-risk-technology-receives-fda-breakthrough-device-designation/