FDA Breakthrough Device designation granted for AI-based mammogram analysis tool

[News]

A new technology that harnesses AI to analyze mammograms and improve the accuracy of predicting a woman's personalized five-year risk of developing breast cancer has received Breakthrough Device designation from the Food and Drug Administration (FDA).

More... (https://www.news-medical.net/news/20250730/FDA-Breakthrough-Device-designation-granted-for-AI-based-mammogram-analysis-tool.aspx)