Arterys has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its cloud-based medical image visualization and quantification software.
The Arterys software has been approved for use in clinical settings for the quantification of cardiac flow, which includes 4D flow and 2D phase contrast workflows, and cardiac function measurements.
It can incorporate into clinical practice to offer comprehensive, simple and quick Cardiac MR imaging. Earlier, the Arterys secured FDA approval for its 4D Flow visualization feature.
Specifically, the new product will analyze the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images in 4D.
The software, which offers clinically-relevant, reproducible and quantitative data, has been tested and validated on MR images acquired from both 1.5T and 3.0T MR scanners.
The data generated by the Arterys software will be used by qualified cardiologists, radiologists, and other licensed healthcare practitioners for clinical decision-making.
Arterys software can be used in clinical applications, including complex congenital heart disease, shunts and collateral vessels, aortic disease and valvular disease.
The company intends to launch the new software in the US through a partnership with GE Healthcare as the ViosWorks 4D product.
Arterys CEO Fabien Beckers said: "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."