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Cloud-based imaging analytics software receives FDA clearance
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Arterys has received 510(k) clearance from the FDA to market a cloud-based imaging analytics application, according to a press release.
The system (Arterys Cardio DL), which received a CE mark in December for commercialization in Europe, provides automated, editable ventricle segmentations based on standard cardiac MRI images, according to the release.
“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,” Arterys CEO Fabien Beckers said in the release.
The application was designed using data collected from cardiac cases and uses a deep learning algorithm, which can be optimized as new data is collected from global users, the company stated in the release.
“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,” Beckers said. “Today’s approval signifies a major regulatory milestone.”
Disclosure: Beckers is an employee of Arterys.