The Ventripoint Medical System Plus (VMS+) is an advanced ultrasound image analysis device that works alongside existing ultrasound systems. It digitally records and processes 3D ultrasound images to help clinicians evaluate the volumes and functions of the heart's left and right ventricles as well as the left and right atria. This aids in detailed cardiac assessment, providing valuable information on heart chamber sizes and function, which supports diagnosis and management of cardiac conditions.
The VMS+ is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. It is indicated for use where Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA), and Right Atrium (RA) volumes and ejection fractions are warranted or desired.
The device is a software-based analysis tool that works adjunctively with ultrasound systems, employing a knowledge-based reconstruction database for 3D image processing and volume measurement of cardiac chambers. It uses real-time video capture, external ECG triggering, and pulsed DC 6DOF magnetic tracking for accurate ultrasound image acquisition and reconstruction.
The device underwent comprehensive electrical, electromagnetic, mechanical safety testing, and standards compliance. Bench testing verified the accuracy of left ventricle, left atrium, and right atrium volume reconstructions via automated and manual methods. Clinical studies were not required for FDA clearance due to substantial equivalence to predicate device.
No predicate devices specified
Submission
12/15/2017
FDA Approval
5/14/2018
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