Artrya Advances US Market Bid with FDA Filing for AI Coronary Plaque Module
Artrya Limited has submitted a pivotal FDA 510(k) application for its AI-powered Salix® Coronary Plaque module, aiming for clearance in Q3 2025 and a lucrative US commercial launch.
- FDA 510(k) submission filed for Salix® Coronary Plaque module
- Module enables near real-time detection of high-risk coronary plaque
- Integration planned with FDA-cleared Salix® Coronary Anatomy platform
- Qualifies for US reimbursement at US$950 per assessment upon clearance
- Strategic partnerships with three US hospital systems underway
FDA Submission Marks a Key Milestone
Artrya Limited, an Australian medical technology innovator, has taken a significant step toward expanding its footprint in the US healthcare market by submitting a 510(k) pre-market application to the US Food and Drug Administration (FDA) for its Salix® Coronary Plaque module. This AI-driven software is designed to provide near real-time, point-of-care detection and quantification of high-risk coronary artery plaque, a critical predictor of heart attacks often overlooked in traditional manual assessments.
The filing follows the earlier FDA clearance of Artrya’s Salix® Coronary Anatomy platform in March 2025, with the new module intended to seamlessly integrate with this existing technology. The company anticipates FDA clearance in the third quarter of 2025, positioning it for a timely commercial rollout in the US.
Commercial and Clinical Implications
Upon clearance, the Salix® Coronary Plaque module will qualify for reimbursement under a Category 1 Current Procedural Terminology (CPT) code, which was upgraded in late 2024 to a reimbursement rate of US$950 per automated plaque assessment. This reimbursement framework is crucial, as it enables Artrya to monetize its technology effectively within the US healthcare system.
Artrya has already secured strategic commercial agreements with three major US hospital systems, Northeast Georgia Health Ventures, Healthliant Ventures, and Cone Health, covering 15 hospitals and numerous outpatient centers. These partnerships will facilitate staged rollouts of the Salix® Coronary Anatomy platform, with the plaque module set to follow swiftly after FDA approval.
Research and Validation Through SAPPHIRE Study
To bolster clinical validation and support broader adoption, Artrya is collaborating with several leading US hospitals on the SAPPHIRE study. This research initiative aims to evaluate whether Artrya’s novel Plaque Dispersion Score (PDS) can more accurately predict patient risk compared to current methods, potentially guiding more personalized therapies for high-risk patients. Data collected via the Salix® Coronary Anatomy platform will feed into a shared registry, supporting both the primary study and future sub-studies.
CEO Mathew Regan highlighted the company’s confidence in the module’s clinical performance, noting that its results closely align with expert clinician assessments. The integration progress with hospital partners underscores Artrya’s readiness for commercial launch pending regulatory approval.
Looking Ahead
The FDA clearance and subsequent reimbursement eligibility represent pivotal catalysts for Artrya’s growth in the competitive US medical technology market. Success in these areas could validate the company’s AI-driven approach to coronary artery disease management and open substantial revenue streams. However, the ultimate impact will depend on the FDA’s decision, hospital adoption rates, and the outcomes of ongoing clinical studies.
Bottom Line?
Artrya’s FDA filing sets the stage for a potential breakthrough in cardiac care technology and US market expansion.
Questions in the middle?
- Will the FDA grant clearance on schedule in Q3 2025?
- How quickly will US hospital partners adopt and scale the Salix® Coronary Plaque module?
- What clinical insights will the SAPPHIRE study reveal about the module’s predictive accuracy?