Australian medical technology company Artrya has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Salix Coronary Plaque module.
The artificial intelligence (AI)-powered module offers near real-time analysis of coronary artery plaque and stenosis at the point of care.
It integrates with Artrya’s Salix Coronary Anatomy platform, providing a streamlined diagnostic tool for coronary artery disease, aiming to improve diagnostic accuracy.
Artrya co-founder and CEO John Konstantopoulos said: “We are thrilled to have received FDA clearance of our Salix Coronary Plaque module, which opens up a much greater revenue opportunity for us in the US, our largest market.
“The team have worked tremendously hard to prepare and support the submission which we lodged on the 16th of June, and we intend to build on this as we approach our next submission for the Salix Coronary Flow module.
“Our momentum is definitely building, with the core Salix Coronary Anatomy platform now commercial in Tanner Health, and integration of Northeast Georgia Health System and Cone Health progressing well.”
Artrya said the FDA clearance opens new commercial opportunities in the US, allowing it to charge fees for using its Salix Coronary Plaque module.
A reimbursement of $950 per scan is expected to be available starting in 2026.
The company’s strategy for the US market focuses on partnerships with mid-sized hospital systems, beginning with Tanner Health.
The partnership with Tanner Health furthers integrations with Northeast Georgia Health and Cone Health are in progress.
Artrya aims to expand its presence by transitioning hospital centres participating in the upcoming SAPPHIRE study into commercial customers.
John added: “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.
“We know these clinicians tremendously value the speed, ease and efficiency that our Salix platform and plaque module offers, as they seek to rapidly diagnose patients and provide those in need with lifesaving treatment.
“As we move forward, our ability to generate revenue from our U.S. customers for each CCTA scan they assess with our Salix Plaque module, provides us the ability to scale rapidly.
“This is underpinned by the ability of our customers to receive an attractive Category 1 reimbursement of $950 for each plaque assessment they perform.”
