Artrya Seeks FDA Approval for AI Coronary Plaque Module

Artrya Limited ( (AU:AYA) ) just unveiled an update.

Artrya Limited has submitted a 510(k) pre-market application to the U.S. FDA for its Salix® Coronary Plaque module, an AI-enabled tool designed for near real-time detection of high-risk coronary plaque, a critical predictor of heart attacks. Expected to receive FDA clearance by the third quarter of 2025, this module will integrate with the already FDA-cleared Salix® Coronary Anatomy platform and is poised to significantly enhance Artrya’s market presence in the U.S. through strategic partnerships with major hospital systems and participation in the SAPPHIRE study. The module’s clearance will also allow Artrya to leverage a U.S. Category 1 CPT code for reimbursement, creating a substantial revenue opportunity.

The most recent analyst rating on (AU:AYA) stock is a Buy with a A$2.21 price target. To see the full list of analyst forecasts on Artrya Limited stock, see the AU:AYA Stock Forecast page.

More about Artrya Limited

Artrya Limited is an Australian medical technology company specializing in AI-powered solutions for the detection and management of coronary artery disease. The company’s proprietary software analyzes coronary CT scans to identify key biomarkers of heart disease, aiding clinicians in more accurate and efficient diagnoses. Artrya is focused on advancing cardiac care through innovative technology, with ongoing regulatory and commercial activities in key international markets.

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Technical Sentiment Signal: Buy

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