Artrya Limited

Artrya on Track for FDA Application Submission Following Second Q-Submission Meeting

Artrya Limited (ASX:AYA), (‘Artrya’ or the ‘Company’), a medical technology company focused on commercialising its patented AI platform that detects key coronary artery disease imaging markers, has received feedback its application for regulatory approval for the Salix product with the US Food and Drug Administration (FDA) is on track following a Q-Submission meeting.


Highlights

  • Feedback and guidance were received during a second Q-Submission meeting held on the evening of 19 August 2024
  • Artrya received feedback its application for regulatory approval for Salix product with the US FDA is on track
  • Artrya plans to submit the 510(k) application to the FDA in the coming weeks.
As stated in Artrya’s 4Q FY24 report to the ASX, the Company had requested a second Q-Submission (Q-Sub) meeting as a key step in the process to finalise its US FDA application for Salix. The meeting was held on the evening of 19 August 2024.

A Q-sub is a formal written request from a company for feedback from the FDA to help guide application preparation. Artrya had requested this second meeting to validate and confirm the approach taken since the first Q-Sub meeting in June 2023.

Artrya CEO Mathew Regan said: "I am pleased to report the outcome of our second Q-sub meeting with the FDA was positive. The FDA provided valuable feedback and guidance on our upcoming application, confirming our approach is on track. This has validated the cautious approach we have taken to ensure we meet all requirements for the 510(k) application. We now have a clear path to submission, and I look forward to lodging our 510(k) application once the formal Q-Sub process is completed.”


Click here for the full ASX Release

This article includes content from Artrya Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.

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