Ventric Health Gets FDA Clearance for Heart Failure Diagnosis Device

It's designed to reduce the impact of heart failure and delay its progression.

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Ventric Health today announced that its medical device, the Vivio System, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). As a result, Vivio empowers clinicians to non-invasively diagnose heart failure within clinical and home health care environments. 

Ventric Health's Vivio System is a mobile, tech-enabled device aiding in heart failure diagnosis. It's designed to reduce the impact of heart failure and delay its progression, allowing for value-based care organizations to improve clinical and health outcomes. Its mobility and simplicity help overcome social determinants of health (SDOH) barriers to diagnosis, like transportation limitations, by enabling trained clinicians to test for elevated LVEDP in the home or in the clinic.

Beneficial for both patients and clinicians, Vivio is designed for mobility and ease-of-use, making it an attractive alternative choice of traditional methods like catheterization or echocardiograms. Its adaptability across care settings and real-time results elevates clinical workflow efficiency while enabling patient-centric care. A recent survey of patients showcased that all respondents found the Vivio test easy to have clinicians perform on them and 95% preferred it to receiving an echocardiogram.

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