Ventric Health Receives FDA 510(k) Clearance for Vivio System

Pasadena, CA-based Ventric Health has received the U.S. FDA 510(k) clearance for the Vivio System™, which enables clinicians to non-invasively diagnose heart failure in clinical and home care settings.

The Vivio System is a mobile device that supports the diagnosis of heart failure using advanced algorithms to rapidly and non-invasively detect elevated LVEDP, enabling value-based care organizations to improve clinical and health outcomes.

Vivio represents a unique quantum step forward in enabling the diagnosis of this costly and deadly condition within Medicare populations. Beneficial for both patients and clinicians, Vivio is designed for mobility and ease of use, making it an attractive choice to traditional methods like catheterization or echocardiograms.

Up to 50% of heart failure patients remain undiagnosed and diagnosis can be delayed up to 30 months after the onset of symptoms. Early diagnosis is critical and Vivio can help clinicians detect the gold standard measure of heart failure, elevated LVEDP, in less than five minutes,” said Sean Brady, co-founder and CEO of Ventric Health.


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