Arterys, a software-as-a-service (SAAS) analytics platform developer, has secured the US Food and Drug Administration (FDA) 510(k) clearance for its Arterys Software.
The clearance will enable usage of the product in clinical settings for the quantification of cardiac flow in the form of 4D flow and 2D Phase Contrast workflows, and cardiac function measurements.
The software easily integrates into clinical practice to facilitate a comprehensive, easy and fast Cardiac MR imaging.
Arterys CEO Fabien Beckers said: "We are thrilled to gain FDA clearance for visualization 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."
The product uses multi-slice, multi-phase and velocity encoded MR images in 4D to specifically analyse the blood flow to the heart.
It provides clinically-relevant and reproducible, quantitative data which has been tested and validated on MR images acquired from both 1.5T and 3.0T MR Scanners.
The data provided by the Arterys Software will support cardiologists, radiologists, and other licensed healthcare practitioners to make clinical decisions.
The Arterys Software will primarily be used for complex congenital heart disease, shunts and collateral vessels, aortic disease and valvular disease.
Arterys is planning to launch the software as ViosWorks 4D product in the US partnering with GE Healthcare.