FDA Clearance Puts Pressure on Artrya to Deliver Rapid U.S. Market Growth

FDA Clearance Marks Major Milestone

Artrya Limited (ASX, AYA), an Australian medical technology innovator, has achieved a significant regulatory breakthrough with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for its Salix Coronary Plaque module. This AI-powered software enhances the detection and quantification of coronary artery plaque, a critical predictor of heart attacks often missed by traditional methods.

The clearance not only validates the technology’s clinical utility but also unlocks a substantial commercial opportunity in the U.S., Artrya’s largest market. The module integrates seamlessly with the company’s existing Salix Coronary Anatomy platform, already deployed commercially with Tanner Health, and soon to be integrated with Northeast Georgia Health System and Cone Health.

Expanding Revenue Potential with Reimbursement

Perhaps most notably, the FDA clearance qualifies the Salix Coronary Plaque module for a Category 1 CPT reimbursement code, enabling healthcare providers to receive approximately US$950 for each coronary CT angiogram (CCTA) scan assessed using the technology. This reimbursement, effective from January 2026, positions Artrya to generate scalable, recurring revenue tied directly to clinical usage.

Coronary artery disease remains the leading cause of death in the U.S. and represents a healthcare expenditure projected to exceed US$1 trillion by 2035. With over 4.4 million CCTA scans performed annually and growing, Artrya’s solution addresses a critical unmet need by providing rapid, near real-time assessments that can be completed in under ten minutes without disrupting clinical workflows.

Strategic Partnerships and Market Traction

Artrya’s go-to-market strategy focuses on partnerships with mid-sized U.S. hospital systems. The commercial agreement with Tanner Health, signed in July 2025, marks the first major deployment of the Salix platform. Integration efforts with Northeast Georgia Health System and Cone Health are progressing, setting the stage for broader adoption.

Additionally, Artrya is collaborating with leading U.S. hospital centers to participate in the upcoming SAPPHIRE study, which will further demonstrate the clinical benefits of the Salix Coronary Plaque module and help transition research sites into commercial customers.

Looking Ahead

CEO John Konstantopoulos expressed optimism about the company’s momentum, highlighting plans to submit the Salix Coronary Flow module for FDA clearance next. The ability to monetize each scan assessed with the plaque module offers a scalable revenue model that could accelerate Artrya’s growth in the competitive cardiac imaging market.

An investor webinar scheduled for 22 August 2025 will provide further insights into the FDA clearance and the company’s strategic outlook.