Artrya secures FDA clearance for Salix Coronary Anatomy

Artrya (ASX:AYA) has received US Food and Drug Administration 510(k) clearance for Salix Coronary Anatomy, enabling its commercial launch in the US.

This marks the first major point-of-care advancement in coronary artery disease assessment in 50 years.

Salix Coronary Anatomy provides a non-invasive, 10-minute assessment following a coronary computed tomography angiogram scan.

It helps physicians analyse arterial plaque, stenosis, and calcification—key factors in heart disease risk assessment.

Ahead of FDA clearance, Artrya partnered with three U.S. hospital groups—Northeast Georgia Health Ventures, Healthliant Ventures of Tanner Health System, and Cone Health—to validate and integrate Salix Coronary Anatomy within their workflows.

The company plans to expand access across 15 hospitals, outpatient centres, and heart and vascular facilities in the southeastern US.

Artrya CEO Mathew Regan stated, "With FDA clearance we can immediately begin the sales cycle, starting with our established hospital partnerships. This will allow us to accelerate commercialisation in the US market, where an estimated 4.4 million CCTA scans are performed annually, growing at over 6% per year."

The company also aims to expedite FDA clearance for Salix Coronary Plaque and Salix Coronary Flow by year-end, unlocking reimbursement codes for advanced plaque and blood flow analysis.