FDA clears Viatronix 3D cardiac application

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Viatronix, a developer of 3D imaging software, has received FDA’s 510(k) market clearance for its V3D-Cardiac module.

The V3D-Cardiac application combines left ventricle and coronary analysis functions into a single user-friendly module, allowing both functions are analyzed in a single application according to the Stony Brook, N.Y.-based company.

Viatronix said that the V3D-Cardiac module has real-time analysis of cardiac CTC data; integration with PACS workstations; one-click segmentation of the heart; one-click selection and analysis of coronary vessels; multi-phase cardiac function review; computation of ejection fraction; coronary vessel endoluminal fly-through; one-click segmentation of the left ventricle and automatic determination of long axis; and customizable reporting is integrated into the workflow.