FDA approves Arterys cardiac MR imaging software
Cloud-based medical imaging software company Arterys announced Wednesday that it has received 510(k) clearance from the FDA for its Arterys Software. The product provides physicians with quick cardiac MR images.
Arterys Software analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase, velocity encoded MR images in 4D. Unlike conventional MRI, where multiple scans are taken while the patient holds their breath, the 4D Flow sequence is provides faster scans and simplified processes.
The software is intended for use in complex congenital heart disease, shunts and collateral vessels, aortic diseases 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.
Arterys plans on launching the product in the U.S. through a partnership with GE Healthcare as the ViosWorks 4D product. The company is also actively pursuing additional regulatory approval in other global markets.