Business
FDA clearance of Salix® Coronary Plaque module
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. This regulatory clearance is a major milestone in Artrya's U.S. market launch which commenced in July and wi
About this update from Artrya Limited
[{"type":"text","content":"Significantly expands U.S. commercial opportunity with ability to charge fees per scan assessed","length":95,"tagName":"p","attribs":{}},{"type":"text","content":"Investor Webinar - 11.30am AEST (9.30am AWST) on 22 August 2025","length":63,"tagName":"p","attribs":{}},{"type":"text","content":"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. This regulatory clearance is a major milestone in Artrya's U.S. market launch which commenced in July and will greatly expand the revenue opportunity with current and future customers.","length":637,"tagName":"p"},{"type":"text","content":"Key Points","length":10,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Major milestone as Artrya receives FDA 510(k) clearance for the Salix® Coronary Plaque module","length":93,"tagName":"p"}]},{"val":[{"type":"text","content":"Salix® Coronary Plaque module enables near real-time, point-of-care detection of high-risk plaque - a key predictor of heart attack[1] often missed using current manual practices","length":178,"tagName":"p"}]},{"val":[{"type":"text","content":"Salix® Coronary Plaque module integrates seamlessly with FDA-cleared Salix® Coronary Anatomy platform which is already commercial with Tanner Health","length":148,"tagName":"p"}]},{"val":[{"type":"text","content":"Significantly expands U.S. commercial launch with ability to charge a fee per scan assessed with Salix® Coronary Plaque module - U.S. Category 1 CPT reimbursement rate US$950[2] for each assessment","length":197,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":616,"olType":false},{"type":"text","content":"John Konstantopoulos, Co-Founder and CEO of Artrya, said:","length":57,"tagName":"p"},{"type":"text","content":""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 sup...