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

Thursday, October 26, 2023

Ventric Health, a healthcare technology company with a focus on cardiovascular health, has received FDA 510(k) clearance for its Vivio System™. This medical device offers a non-invasive solution for diagnosing heart failure in clinical and home healthcare settings. In the United States, heart failure affects approximately 6.5 million people, with an additional 550,000 new cases diagnosed annually.

The Vivio System, developed by Ventric Health, stands out as a mobile, technology-enabled device designed to aid in heart failure diagnosis. It utilizes advanced algorithms for the swift and non-invasive detection of elevated LVEDP, offering critical clinical insights for healthcare professionals across various care settings. This achievement underscores Ventric Health's commitment to delivering transformative clinical interventions in cardiovascular health. 

Vivio represents an innovative approach to heart failure diagnosis, aiming to reduce its impact and delay its progression. This allows value-based care organizations to enhance clinical and health outcomes. Its mobility and user-friendly design address obstacles related to social determinants of health (SDOH), such as transportation limitations. Trained clinicians can use it to assess elevated LVEDP in both home and clinical environments. This benefits both patients and healthcare providers, offering a mobile and user-friendly alternative to traditional methods like catheterization or echocardiograms. Vivio's adaptability across different care settings and provision of real-time results streamline clinical workflows while promoting patient-centered care.



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