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Artrya Advances FDA Submission for Salix® Coronary Flow Module

Story Highlights
  • Artrya held a successful Q-Submission meeting with the FDA for its Salix® Coronary Flow module.
  • FDA guidance will be incorporated into the 510(k) application, expected by year-end.
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Artrya Advances FDA Submission for Salix® Coronary Flow Module

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Artrya Limited ( (AU:AYA) ) has issued an update.

Artrya Limited announced a successful Q-Submission meeting with the U.S. FDA regarding its Salix® Coronary Flow module, a significant step towards obtaining 510(k) regulatory clearance. The FDA provided clear guidance for the application process, which Artrya will incorporate into its final submission expected by the end of the year. This development follows the earlier approval of the Salix® Coronary Plaque module and underscores Artrya’s commitment to advancing its AI-powered cardiac care solutions.

The most recent analyst rating on (AU:AYA) stock is a Buy with a A$3.51 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 software analyzes coronary CT scans to identify key biomarkers, aiding clinicians in more accurate and efficient diagnosis. Artrya is focused on advancing cardiac care through innovative technology and is active in regulatory and commercial activities across key international markets.

Average Trading Volume: 666,191

Technical Sentiment Signal: Buy

Current Market Cap: A$378M

Find detailed analytics on AYA stock on TipRanks’ Stock Analysis page.

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