Ventric Health has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its heart failure diagnosis device, the Vivio System.
The mobile, tech-enabled device will enable clinicians to non-invasively diagnose heart failure in home healthcare and clinical environments.
Leveraging advanced algorithms, Vivio can rapidly detect increased left ventricular end-diastolic pressure (LVEDP) non-invasively.
The device aims to minimise the effects of heart failure and slow down its advancement, enabling value-based care organisations to enhance clinical and health results.
Designed for ease of use and mobility, the device serves as a better option than conventional approaches such as echocardiograms or catheterisation.
Its ability to work in various healthcare settings and deliver real-time results improves clinical workflow efficiency and patient-centred care.
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Ventric Health co-founder and CEO Sean Brady said: “Up to 50% of heart failure patients are undiagnosed and diagnosis can lag up to 30 months following the initial onset of symptoms.
“Early diagnosis is crucial for treating and managing heart failure in our most vulnerable populations, those that are 65 years or older.
“Now with the introduction of Vivio, clinicians can detect the gold standard measurement of heart failure, elevated LVEDP, in less than five minutes—and can do so in any care setting.”
Approximately 6.5 million people in the US experience heart failure and an additional 550,000 new cases are diagnosed annually.
By 2030, it is estimated that heart failure will contribute to $70bn in US healthcare costs.