FDA clearance of Salix® Coronary Plaque module

PERTH, Australia, Aug. 21, 2025 /PRNewswire/ -- Artrya Limited (ASX: AYA) (Artrya or the Company), a medical technology company commercialising its Salix® AI-powered cloud platform, for the near real time, point of care assessment and management of coronary artery disease, is pleased to announce it has received 510(k) clearance from the U.S. Food and Drug Administration (the FDA) for Artrya's proprietary, Salix® Coronary Plaque module.

John Konstantopoulos, Co-Founder and CEO of Artrya, 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 U.S., 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. 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.

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