Imaging software developer Arterys has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new software to provide 4D views of the entire heart.
The agency's approval allows the company to market the software for clinical settings to support diagnoses of cardiovascular anomalies and disease.
Arterys developed its entire platform to enable the processing of imaging data in the cloud. The software is also designed to collect and process large datasets in real-time and produce enhanced color renderings of the heart's anatomy.
