Artrya’s Salix Coronary Plaque Module Cleared by FDA

August 25, 2025—Artrya Limited announced it has received 510(k) clearance from the FDA for the Salix coronary plaque module. The module is part of the Salix artificial intelligence–powered coronary anatomy cloud platform, which was commercially launched in July.

According to the Australia-based company, the Salix coronary plaque module is intended for detecting and quantifying coronary artery plaque. It enables a near real-time, point-of-care assessment of plaque and stenosis for patients who have undergone a coronary CT angiogram.

Artrya stated that the coronary plaque module is already embedded within the same user interface as the Salix coronary anatomy platform and can immediately be enabled in the live version of the platform after this FDA clearance.

The expanded Salix technology allows clinicians to access assessments in < 10 minutes, without changing or using multiple systems, noted the company.

The company also advised that it is collaborating with major hospital centers in the United States in the upcoming SAPPHIRE study, which will use the Salix coronary plaque module to gain awareness and understanding of the benefits of Salix.