FDA Grants Breakthrough Device Designation to AI-Powered Mammogram Analysis Tool for Breast Cancer Risk Prediction

3 Sources

A new AI-based technology developed by Washington University School of Medicine researchers has received FDA Breakthrough Device designation. The software analyzes mammograms to predict a woman's five-year risk of developing breast cancer with improved accuracy.

Breakthrough in Breast Cancer Risk Assessment

A groundbreaking artificial intelligence (AI) technology for analyzing mammograms has received Breakthrough Device designation from the Food and Drug Administration (FDA). Developed by researchers at Washington University School of Medicine in St. Louis, this innovative software aims to significantly improve the accuracy of predicting a woman's personalized five-year risk of developing breast cancer 1.

The Prognosia Breast System

Source: newswise

Source: newswise

The software package, named Prognosia Breast, was created by Dr. Graham A. Colditz and Dr. Shu (Joy) Jiang. It utilizes a pre-trained machine learning system to analyze mammogram images and estimate a patient's likelihood of developing breast cancer over the next five years, based solely on images and the woman's age 2.

According to the developers, Prognosia Breast estimates a person's five-year risk of developing breast cancer 2.5 times more accurately than standard methods, which rely on questionnaires considering factors such as age, race, and family history 3.

Advanced Features and Compatibility

Source: News-Medical

Source: News-Medical

The system is compatible with both 2D full-field digital mammography and 3D digital breast tomosynthesis imaging techniques. It produces an absolute five-year risk score, allowing for comparison with average risk based on national breast cancer incidence rates. This alignment with U.S. national risk reduction guidelines enables clinicians to determine appropriate next steps for women with elevated risk 1.

Potential Impact on Breast Cancer Detection

The new technology could have a significant impact on risk prediction and early detection. With the infrastructure already in place for immediate implementation in mammography centers, it has the potential to reduce the number of late-stage cancer diagnoses. Currently, about 34% of breast cancer patients in the U.S. are diagnosed at later stages of the disease 2.

FDA Breakthrough Device Designation

The FDA Breakthrough Device designation provides an expedited review process for full market approval, aiming to accelerate patient and clinician access to promising new medical devices. This designation is awarded to products that have undergone rigorous testing and shown excellent potential to improve treatment or diagnosis of life-threatening conditions 3.

Source: Medical Xpress

Source: Medical Xpress

Future Prospects and Implementation

Dr. Colditz expressed excitement about the technology's potential to improve risk prediction and prevention of breast cancer globally. The long-term goal is to make this technology available to any woman having a screening mammogram anywhere in the world 2.

The device is intended to complement, not replace, the analysis provided by radiologists. According to guidelines from the American Society of Clinical Oncology and the U.S. Preventive Services Task Force, women with a five-year risk score of 3% or higher are considered to have elevated risk and should be referred to specialists for further advice on additional screening and prevention strategies 1.

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