Artera Receives FDA Clearance for ArteraAI Breast
Artera has announced the U.S. FDA clearance of ArteraAI Breast, a digital pathology-based risk stratification tool designed for patients with early-stage, hormone receptor-positive (HR+), HER2-negative invasive breast cancer. This marks the first FDA-cleared tool of its kind for breast cancer, building upon Artera’s existing clearance for prostate cancer detection.
SAN FRANCISCO–(BUSINESS WIRE)–Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, today announced U.S. Food and Drug Administration (FDA) clearance of ArteraAI Breast for use in patients with early-stage, hormone receptor-positive (HR+), HER2-negative invasive breast cancer. ArteraAI Breast is the first and only FDA-cleared digital pathology-based risk stratification tool for breast cancer. With clearances in both prostate and breas