Artrya Receives FDA Clearance for AI-Powered Coronary Plaque Detection Module, Expands US Revenue Opportunity
Key Insights
Artrya Limited (search) received FDA 510(k) clearance for its Salix® Coronary Plaque module (search), an AI-powered tool that enables near real-time detection of high-risk coronary plaque (search) in under 10 minutes.
The FDA clearance significantly expands Artrya's US commercial opportunity, allowing the company to charge fees per scan with US$950 Category 1 CPT reimbursement available from January 2026.
The module integrates seamlessly with Artrya's existing FDA-cleared Salix® Coronary Anatomy platform (search), which is already commercial with Tanner Health (search) and being integrated with additional hospital systems.
Artrya Limited (search) has received FDA 510(k) clearance for its Salix® Coronary Plaque module (search), marking a significant milestone in the Australian medical technology company's US market expansion. The AI-powered module enables near real-time, point-of-care detection of high-risk coronary plaque (search), a key predictor of heart attack (search) that is often missed using current manual practices.
The regulatory clearance opens substantial revenue opportunities for Artrya, as the company can now charge fees per scan assessed with the Salix® Coronary Plaque module (search). Healthcare providers will be able to receive US$950 Category 1 CPT reimbursement for each plaque assessment performed starting January 1, 2026.
Seamless Integration with Existing Platform
The Salix® Coronary Plaque module (search) integrates directly with Artrya's FDA-cleared Salix® Coronary Anatomy platform (search), which is already commercial with Tanner Health (search). The module is embedded within the same user interface and can be immediately enabled in the live version of the platform following FDA clearance, providing clinicians with assessments in less than 10 minutes without requiring multiple systems.
"We are thrilled to have received FDA clearance of our Salix® Coronary Plaque module (search), which opens up a much greater revenue opportunity for us in the U.S., our largest market," said John Konstantopoulos, Co-Founder and CEO of Artrya. "Once live, we simply enable the Salix® Coronary Plaque module in their workstream, providing their clinicians access to our highly detailed assessment of coronary artery plaque in under ten minutes."
Addressing Critical Medical Need
Coronary artery disease (search) remains the leading cause of death and the largest category of US healthcare expenditure, with costs projected to exceed US$1 trillion by 2035. The disease presents significant diagnostic challenges, as coronary artery plaque remains difficult to detect with current methods and in over 50% of the population, the first sign of the disease is sudden death.
The Salix® Coronary Plaque module (search) addresses this critical gap by providing artificial intelligence-enabled detection and quantification of coronary artery plaque for patients who have undergone coronary CT angiography (CCTA), which is now the recommended front-line diagnostic scan for assessing patients with known or suspected coronary artery disease (search).
Market Opportunity and Commercial Strategy
More than 4.4 million CCTA scans are performed annually in the US, with the market growing at over 6% per year. The US government has increased reimbursement rates for assessing CCTA scans due to the high incidence of coronary artery disease (search) and benefits of earlier intervention.
Artrya's go-to-market strategy focuses on three strategic partnerships with mid-sized US hospital systems. Tanner Health (search) signed a commercial agreement for clinical use of the Salix® Coronary Anatomy platform (search) in July 2025, while integration with Northeast Georgia Health System (search) and Cone Health (search) is progressing and expected to be completed in the coming months.
Financial Backing and Future Plans
The company recently completed an A$80 million follow-on equity offering to support its US launch, reflecting strong investor enthusiasm for Artrya's expansion plans and advances in AI-enabled cardiology diagnostics. Despite having only A$28,000 in annual revenue currently, the significant capital injection positions Artrya to accelerate its US rollout.
Artrya is also collaborating with several major US hospital centers to participate in the upcoming SAPPHIRE study, where centers will use the Salix® Coronary Plaque module (search) and gain awareness of the platform's benefits. The company plans to leverage this clinical utility to transition participating centers into commercial customers.
The FDA submission for the Salix® Coronary Plaque module (search) was lodged on June 16, 2025, with Artrya now preparing its next submission for the Salix® Coronary Flow module as it continues to expand its AI-powered cardiac diagnostic capabilities.