FDA Clears Use of AI Tool Designed to Predict Whether Breast Cancer Will Recur

FDA clears use of AI tool designed to predict whether breast cancer will recur

The U.S. Food and Drug Administration has given clearance for the use of an AI tool designed to help predict the chances that breast cancer will come back after treatment, the product’s maker says.

AI tool receives FDA clearance to predict breast cancer recurrence

Tumor Site Risk received FDA clearance to help women assess their long-term risk of breast cancer recurrence.

SimBioSys Secures FDA Clearance for TumorSight® Risk, Introducing the World’s First AI-Powered, MRI-Derived Breast Cancer Recurrence Risk Assessment

SimBioSys® announced US FDA 510(k) clearance of TumorSight® Risk, the world’s first AI-powered, MRI-derived prognostic tool for assessing breast cancer recurrence risk. [SimBioSys] Press Release