FDA grants clearance to cloud-based medical imaging analytics software

The U.S. Food and Drug Administration (FDA) has granted Arterys—a cloud-based medical imaging software—clearance to market its Arterys Cardio DL application. This marks the first time the agency has approved of a technology that leverages cloud computing and deep learning in a clinical setting.

Arterys Cardio DL provides automated, editable ventricle segmentations based on conventional cardiac MRI images that are as accurate as segmentations performed manually by experienced physicians.

"Arterys is committed to broadly accelerate the transformation of data-driven medicine through advanced cloud medical imaging analytics applications while always protecting patient data privacy," said Fabien Beckers, Arterys CEO. "Today's approval signifies a major regulatory milestone. This application demonstrates the power of deep learning combined with cloud supercomputation to aid physicians in interpreting medical images—eliminating tedious manual tasks carried out on a workstation by accurately automating those processes."

FDA clearance allows Arterys to use its clinical annotation platform to collect patient data every time a physician views a study on Arterys.com. It also allows Arterys to expand on its 4D Flow post-processing software that allows physicians to view comprehensive anatomy and blood flow visualization and quantification within and around the heart in a more simplified manner.