ArteraAI Breast Gains FDA Clearance as First AI-Powered Digital Pathology Risk Stratification Tool for Breast Cancer

Artera announced that the FDA granted clearance for ArteraAI Breast, the first and only FDA-cleared digital pathology-based risk stratification tool for early-stage hormone receptor-positive (HR+), HER2-negative invasive breast cancer. The platform combines digitized histopathology images with patient clinical variables to classify patients into low-risk and high-risk categories for distant metastasis. The clearance expands Artera's multimodal AI platform beyond prostate cancer into breast oncology, following recent CE Mark approvals in Europe for both ArteraAI Prostate and ArteraAI Breast assays. Data presented at the 2025 San Antonio Breast Cancer Symposium demonstrated the platform's ability to help identify patients who may derive benefit from chemotherapy treatment.