Arterys Receives 510(k) Clearance for Arterys Software

Arterys has received 510(k) clearance from the FDA for its software for cloud-based medical image visualization and quantification.

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.

Arterys now plans on launching the product in the U.S. through a partnership with GE Healthcare as the ViosWorks 4D product. — Cynthia Jessup