January 9, 2017 — Arterys has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Arterys Cardio DL application. Arterys Cardio DL is the first technology to be cleared by the FDA that leverages cloud computing and deep learning in a clinical setting.
Arterys Cardio DL provides automated, editable ventricle segmentations based on conventional cardiac magnetic resonance imaging (MRI) exams that are as accurate as segmentations performed manually by experienced physicians. The U.S. clearance complements the CE Mark received in late December for commercialization of the Arterys Cardio DL product in Europe.
The application is vendor-agnostic and was developed using data from several thousand cardiac cases. The software produces editable automated contours, providing precise and consistent ventricular function in seconds. The trained deep learning algorithm was validated as producing results within an expected error range comparable to that of an experienced clinical annotator. This clearance enables Arterys to make use of its unique clinical annotation platform, which collects ground-truth data every time a user views a study on Arterys.com. In the future, the deep learning model can be optimized as new data is collected from all global users.
Both the FDA clearance and CE Mark expands on the recently 510(k) cleared 4D Flow post-processing software features that provide comprehensive anatomy and blood flow visualization and quantification within and around the heart in a simple manner.
For more information: www.arterys.com
November 17, 2025 
