Artera receives FDA clearance for AI-powered breast cancer risk stratification tool

Artera received FDA clearance on May 11 for ArteraAI Breast, a digital pathology-based risk stratification tool for patients with early-stage, hormone receptor-positive (HR+), HER2-negative invasive breast cancer. The tool generates an AI-derived risk score using digitized histopathology images and patient clinical variables to stratify patients into low- and high-risk groups for distant metastasis. It is the first and only FDA-cleared digital pathology-based risk stratification tool for this breast cancer subtype. The clearance follows Artera's earlier FDA De Novo authorization for its AI prostate cancer tool and recent CE Marking for both assays, expanding the company's regulatory footprint across the US and Europe. Yale Cancer Center director Eric Winer called it 'an important advance on the road to personalizing treatments for patients with early-stage breast cancer.'