Artrya (AYA) FDA Announcement summary

Introduction and purpose

• FDA 510(k) clearance granted for the Salix Coronary Plaque Module, an AI-powered tool for real-time, point-of-care detection and quantification of coronary artery plaque.

• The technology aims to improve detection and management of coronary artery disease, the leading cause of death in the U.S.

• The call aimed to explain the significance of the clearance and its commercial implications, especially in the U.S. market.

Details of approval or decision

• The Salix Coronary Plaque Module received FDA clearance, enabling real-time, automated plaque analysis integrated into the existing platform for U.S. customers.

• The module processes CCTA scans without human intervention, differentiating it from competitors.

• The module qualifies for a Category I CPT code, enabling $950 reimbursement per assessment from January 1, 2026.

• Immediate availability for clinicians as part of the platform rollout.

Impact on industry and stakeholders

• Opens access to a $4.4 billion U.S. market with 4.4 million annual CCTA scans, growing at 6% per year.

• Expands commercial opportunities by enabling per-scan fees and rapid scaling in the U.S. market.

• Enables hospitals to become profit centers due to favorable reimbursement, supporting increased CCTA volumes.

• Strategic partnerships with U.S. hospital systems are in place, with further integrations planned.

• Structured rollout with initial focus on three hospital systems performing 15,000 scans annually, with future expansion via the SAPPHIRE study partners (400,000 scans/year).