FDA Clears Coronary Plaque Software Module for Coronary CT Angiography

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Salix Coronary Plaque module, an artificial intelligence (AI)-enabled software module that may allow detection of high-risk coronary plaque within minutes. Emphasizing that high-risk plaque is a significant predictive factor with heart attacks, the automated assessments of coronary computed tomography angiography (CCTA) scans with the Salix Coronary Plaque module provide essential diagnostic efficiency, according to Artrya, the developer of the software module. “Once (the module is) live, we simply enable the Salix® Coronary Plaque module in their workstream, providing … clinicians access to our highly detailed assessment of coronary artery plaque in under ten minutes,” noted John Konstantopoulos, the CEO and co-founder of Artrya. Artrya added that use of the Salix Coronary Plaque module for plaque analysis qualifies for Category 1 CPT reimbursement of $950 as of January 1, 2026.