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Ventripoint Diagnostics applies for US market clearance for VMS+

The VMS+ device has already passed the ISO 60601 testing.
Heart symbol
The submission uses the existing VMS as the predicate device

VentriPoint Diagnostics Ltd (CVE:VPT) has applied to the Food and Drug Administration (FDA) for clearance for its VMS+ whole-heart analysis system to go on sale.

The medtech company has submitted a traditional 510(k) application to the FDA's Center for Devices and Radiological Health (CDRH) to request clearance for sale of the VMS+ system, which allows for analysis of all four chambers of the heart.

The submission uses the existing VMS as the predicate device and provides testing data to show that the databases for the left atrium, right atrium and left ventricle perform equally well in assessing the chamber volumes in a wide variety of heart conditions, and shapes and sizes of hearts.

The VMS+ is the first cost-effective and accurate artificial intelligence tool for measuring whole heart function using conventional ultrasound.

READ VentriPoint Diagnostics makes major stride with VMSplus receiving CE mark​

Describing the application it as a “milestone event," George Adams, the chief executive officer of Ventripoint, said: "The company is focused on making cardiac ultrasound assessments faster, easier and available to all to overcome the costs, delays and limitations of cardiac MRI." 

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