Artrya (ASX:AYA) has taken an essential step toward US clearance of its Salix Coronary Flow module, confirming a successful Q-Submission meeting with the Food and Drug Administration that provided clear guidance for a 510(k) application.
The company said the agency affirmed that 510(k) is the appropriate regulatory pathway. A 510(k) submission is a premarket notification required by the FDA for most medium-risk medical devices (Class II) before they can be marketed in the US. The primary purpose of a 510(k) is to demonstrate that the new medical device is substantially equivalent in safety and effectiveness to a legally marketed device, known as a predicate device, that is already on the US market.
Artrya will now refine its study design and submission to incorporate the FDA’s feedback ahead of a planned filing by the end of the calendar year.
Co-founder and CEO John Konstantopoulos said the company will mirror the approach used for Salix Coronary Plaque, which secured FDA clearance in August, prioritising a clinical package and high-quality dossier to support an expedited review.
The Coronary Flow module is designed to extend Salix’s cloud-based, AI-enabled assessment of coronary artery disease into near real-time, point-of-care insights on flow, complementing plaque analysis to help clinicians diagnose and manage patients more accurately and efficiently.
Q-Sub meetings are a standard part of US device development, enabling sponsors to test assumptions on intended use, validation requirements and submission structure before filing. For Artrya, the feedback anchors its regulatory plan and reduces execution risk as it advances Salix Coronary Flow toward the market. The company emphasised that the 510(k) package will be updated immediately to reflect the FDA’s recommendations, to maintain momentum from its recent U.S. clearance.