Artrya Limited ( (AU:AYA) ) has provided an announcement.
Artrya Limited has submitted its response to the US FDA’s queries regarding its 510(k) application for the Salix® Coronary Anatomy product, which is part of the regulatory process for obtaining approval. The company expects to receive regulatory clearance by the end of March 2025, marking a significant milestone in its regulatory pathway. This development is crucial for Artrya’s operations and industry positioning, as it progresses towards offering its AI-based coronary disease detection technology in the US market.
More about Artrya Limited
Artrya Limited, based in Perth, Australia, is an applied artificial intelligence healthcare company founded in 2018 and listed on the Australian Securities Exchange in 2021. The company focuses on improving the diagnosis of coronary heart disease through its AI platform, which works alongside clinicians to provide a comprehensive overview of at-risk patients. Artrya’s deep-learning algorithms aim to predict and prevent acute coronary events, with regulatory submissions pending for clearance and approval in the US.
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