Arterys has received 510(k) clearance from the FDA for its Arterys Software. This clearance allows the Arterys product to be used in clinical settings for the quantification of cardiac flow, which includes 4D flow and 2D phase contrast workflows, and cardiac function measurements. The product is deigned to seamlessly integrate into clinical practice to provide comprehensive, simple and quick cardiac magnetic resonance (MR) imaging. Previously, the Arterys Software received FDA clearance for its 4D Flow visualisation feature.
According to a press release, the product specifically analyses the blood flow to the heart and its major vessels using multislice, multiphase and velocity encoded MR images in 4D. It provides clinically-relevant and reproducible, quantitative data, and it has been tested and validated on MR images acquired from both 1.5T and 3.0T MR Scanners. The data produced by the Arterys Software is intended to be used to support qualified cardiologists, radiologists, and other licensed healthcare practitioners for clinical decision-making. The main clinical applications of the Arterys Software include complex congenital heart disease, shunts and collateral vessels, aortic disease and valvular disease.
Fabien Beckers, chief executive officer of Arterys, says: “We are thrilled to gain FDA clearance for visualisation and quantification of cardiovascular MR images. The entire Arterys team is committed to providing technology that is valuable to clinicians and also improves their workflow. We believe that our 4D Flow software represents a significant advance in medical imaging, making scans more accessible, useful, and practical for patients and medical professionals.”
Following FDA clearance, Arterys plans on launching the product in the US through a partnership with GE Healthcare as the ViosWorks 4D product. The company is also actively pursuing additional regulatory approval in other global markets.