Artrya Targets Year-End FDA 510(k) Submission for Coronary Flow Module
Artrya Limited has successfully navigated a key FDA Q-Submission meeting, receiving clear guidance on the regulatory pathway for its Salix Coronary Flow module, with a 510(k) submission planned by year-end.
- FDA confirms 510(k) as regulatory route for Salix Coronary Flow
- Q-Submission meeting provides detailed FDA feedback
- Artrya to update study design and application accordingly
- Final 510(k) submission targeted by end of 2025
- Follows recent FDA approval of Salix Coronary Plaque
Artrya Advances Regulatory Milestone
Artrya Limited, an Australian medical technology innovator, has taken a significant step forward in its U.S. regulatory journey with the Salix Coronary Flow (SCF) module. The company announced the successful completion of a Q-Submission meeting with the U.S. Food and Drug Administration (FDA), a formal process designed to obtain feedback on regulatory strategy before submitting a pre-market application.
This meeting is a critical checkpoint for Artrya, which is commercialising AI-powered software aimed at improving the diagnosis and management of coronary artery disease. The FDA’s confirmation that the 510(k) pre-market notification is the appropriate regulatory pathway provides clarity and direction for the company’s next steps.
Guidance Shapes Next Phase
During the Q-Submission, the FDA offered constructive feedback on the study design and clinical validation requirements for the Salix Coronary Flow module. Artrya plans to incorporate this guidance into its updated 510(k) application, mirroring the approach it successfully employed for its Salix Coronary Plaque product, which received FDA clearance earlier this year.
John Konstantopoulos, Artrya’s Co-Founder and CEO, highlighted the importance of this interaction, noting that the FDA’s clear pathway and feedback will help streamline the approval process. The company intends to focus on a robust clinical study and a high-quality submission to support an expedited review.
Looking Ahead to Submission
Artrya aims to submit the final 510(k) pre-market application for the Salix Coronary Flow module by the end of the calendar year, marking a pivotal moment in its expansion into the U.S. market. This submission will be closely watched by investors and industry observers, as FDA clearance could significantly enhance the company’s commercial prospects and reinforce its position in the competitive medical technology sector.
With coronary artery disease remaining a leading cause of mortality worldwide, innovations like Artrya’s AI-driven platform have the potential to transform clinical workflows and patient outcomes. The company’s progress underscores the growing role of artificial intelligence in healthcare diagnostics and the importance of regulatory alignment in bringing these technologies to market.
Bottom Line?
Artrya’s clear FDA pathway sets the stage for a critical submission that could accelerate its U.S. market entry.
Questions in the middle?
- What specific clinical data will Artrya include to satisfy FDA requirements?
- How might FDA feedback influence the timeline or scope of the Salix Coronary Flow launch?
- What are the commercial implications if FDA clearance is delayed or requires additional data?
