Arterys Software Cleared for Cloud-Based Cardiac Medical Image Visualization and Quantification

November 7, 2016—Arterys, Inc., a developer of cloud-based medical imaging software, announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Arterys software to be used in clinical settings for the quantification of cardiac flow, including four-dimensional (4D) flow and two-dimensional (2D) phase contrast workflows, and cardiac function measurements.

The company plans on launching the product as the ViosWorks 4D in the United States through a partnership with GE Healthcare. The company is also pursuing regulatory approval in international markets.

According to Arterys, the product integrates into clinical practice to provide comprehensive, simple, and quick cardiac magnetic resonance (MR) imaging. The Arterys software previously received FDA clearance for its 4D flow visualization feature.

The product software analyzes 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 health care 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.