FDA OKs Arterys' cardiac MRI analysis software

Cloud-based medical imaging player Arterys has earned an FDA clearance for its Arterys software, which can now be used to noninvasively quantify cardiac flow and measure heart function in clinical settings.

"We are thrilled to gain FDA clearance for visualization and quantification of cardiovascular MR images," said CEO Fabien Beckers in a statement. "… 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 software analyzes multislice, multiphase and velocity-encoded MR images in 4D to assess blood flow to the heart and its major blood vessels, according to the statement. It is compatible with imagers from both 1.5-tesla and 3-tesla MR scanners and generates “reproducible, quantitative data,” which can be used to help cardiologists, radiologists and other clinicians make treatment decisions.


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The software’s applications range from congenital heart disease and aortic and valvular disease to shunts and collateral vessels, according to the statement. Arterys’ cloud platform allows for the real-time collection and analysis of large data sets, accelerating cardiac examinations.

"It's not possible for physicians to process all this data themselves," Beckers previously told FierceMedicalDevices. "We take advantage of neural networks to process all this data. We have reached the limit on how much a single computer and a single doctor can do with data."

Now, the company expects to launch the product in the U.S. through its partnership with GE Healthcare. The Arterys software will be commercialized via GE’s ViosWorks application for GE MRI scanners.

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