Arterys Receives 510(k) Clearance for Arterys Software
News Nov 05, 2016
Arterys has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (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 seamlessly integrates into clinical practice to provide comprehensive, simple and quick Cardiac MR imaging. Previously, the Arterys Software received FDA clearance for its 4D Flow visualization feature.
"We are thrilled to gain FDA clearance for visualization and quantification of cardiovascular MR images," said Fabien Beckers, CEO, Arterys. "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 specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase 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.
"Since our founding just five years ago, Arterys has been committed to transforming clinical practice through powerful, quantitative imaging analytics that rapidly capture and analyze unprecedented amounts of data for use in guiding treatment decisions and patient care," said CTO John Axerio-Cilies.
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.
Original article from Arterys. Please note: The content may have been edited to ensure it is in keeping with Technology Networks' style and length guidelines.