Arterys has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Cardio DL zero-footprint medical imaging analytics cloud software.
The software is claimed to be the first FDA-approved technology that leverages cloud computing and deep learning in a clinical setting.
The Cardio DL software will offer automated and editable ventricle segmentations based on conventional cardiac MRI images.
Last December, the firm also received CE mark approval for Cardio DL application.
Arterys Cardio DL application, which was vendor agnostic, has been developed by using data from several thousand cardiac cases.
The trained deep learning algorithm will produce editable automated contours, offering precise and consistent ventricular function in seconds.
Both the approvals are said to expand 4D Flow post-processing software, which offers comprehensive anatomy and blood flow visualization and quantification within and around the heart.
Artery’s medical imaging analytics platform will enhance the ability of cloud computation and deep learning to support automated post-processing, diagnostic and therapeutic decisions.
Arterys CEO Fabien Beckers said: "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.
“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."
Image: Arterys Cardio DL uses deep learning to automate time consuming analyses and tasks that are performed manually by clinicians. Photo: courtesy of PRNewsFoto / Arterys.