FDA OK's Arterys cardiac software

Imaging software developer Arterys has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Arterys Cardio DL application, which uses cloud computing and deep learning.

Cardio DL provides automated, editable ventricle segmentations based on cardiac MR images, and was developed using data from several thousand cardiac cases. The deep-learning algorithm was validated as producing results within an expected error range comparable with that of an experienced clinician, the firm said.

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