Australian medical technology company Artrya (ASX:AYA) has submitted its application for regulatory approval for the Salix Coronary Anatomy product to the US FDA.
Salix is a web-based software tool for medical professionals to use interactively to view and analyse cardiac computed tomography data and determine the presence and extent of coronary plaques and stenosis.
The company said the submission follows feedback from the FDA in two Q-Submission meetings in June and August 2024.
CEO Mathew Regan said, " I am pleased to report that Artyra has submitted its FDA application for regulatory approval of our Salix Coronary Anatomy product, after completing all the key stages of preparation. We look forward to hearing from the FDA in due course. Over the last 10 months we have also worked with US hospital groups and healthcare systems in strategic agreements to do final testing and validation on the Artrya system, which will allow us to reduce the sales cycle post FDA approval.”