FAQs Archive - Page 6 of 9

Q: Can Vivio® be used outside traditional clinic environments?

Yes. Vivio ® is mobile and non-invasive, making it suitable for home visits, community clinics, and post-acute care settings.

Q: Does Vivio® support consistent decision-making across providers?

Vivio ® provides standardized physiological insights that help align clinical assessment and escalation decisions across teams. Vivio system test result output has been audited by an independent consultant and meets the requirements for a heart failure diagnosis.

Q: What population health problems does Vivio® address?

Vivio ® supports management of large at-risk populations where heart failure is underdiagnosed, particularly among aging patients and those with multiple chronic conditions.

Q: What types of patients benefit most from Vivio® testing?

Patients who are at high-risk of heart failure because of ongoing diabetes, chronic kidney disease, with symptoms such as shortness of breath, fatigue, edema, hypertension, diabetes, or other cardiovascular risk factors are observed to benefit from earlier screening.

Q: Can Vivio® be used in a typical primary care workflow?

Yes. Vivio ® is designed to integrate into routine visits without disrupting patient flow or requiring specialized facilities.

Q: Is Vivio® FDA-cleared?

Yes. Vivio ® received 510(k) clearance from the U.S. Food and Drug Administration to indicate elevated filling pressure in October 2023 — making it the only FDA-cleared non-invasive medical device of its kind.

Q: Does Vivio® replace echocardiography or catheterization?

No. Vivio ® is designed to identify if patients who are at-risk for heart failure have elevated LVEDP – the clinical hallmark of heart failure - and get them started on frontline GDMT as soon as possible. Vivio is useful in that it is highly sensitive to finding early stage heart failure and is easy-to-use at the primary care setting. With its higher sensitivity, Vivio will identify patients with elevated filling pressures that an echo may not detect, which enables earlier and more widespread GDMT utilization. While the Vivio can be used as a standalone to diagnose heart failure, the echo may be helpful for characterizing functional issues in segments of the population, for example, to determine if the type of heart failure is HFpEF or HFrEF. Both echocardiography and cardiac catheterization provide information beyond elevated LVEDP.

Q: What exactly does Vivio® measure?

Vivio ® indicates whether left ventricular end-diastolic pressure (LVEDP) is elevated, specifically - >18mmHg, which correlates with worsening cardiac function and heart failure .

How does Vivio^® help patients who struggle to access specialty care?

Ventric Health2026-04-21T19:06:32+00:00March 17, 2026|For Home Health & Community-Based Care Teams|

By bringing advanced cardiovascular assessment directly to the patient, Vivio® [...]

Can Vivio^® be used outside traditional clinic environments?

Ventric Health2026-04-21T16:24:41+00:00March 17, 2026|For Home Health & Community-Based Care Teams|

Yes. Vivio® is mobile and non-invasive, making it suitable for [...]

Does Vivio^® support consistent decision-making across providers?

Ventric Health2026-04-21T19:05:28+00:00March 17, 2026|For Value-Based Care Organizations & Health Systems|

Vivio® provides standardized physiological insights that help align clinical assessment [...]

What population health problems does Vivio^® address?

Ventric Health2026-04-21T19:04:47+00:00March 17, 2026|For Value-Based Care Organizations & Health Systems|

Vivio® supports management of large at-risk populations where heart failure [...]

How does Vivio^® support value-based care models?

Ventric Health2026-04-21T19:03:10+00:00March 17, 2026|For Value-Based Care Organizations & Health Systems, Outcomes & Benefits, Value-Based Care & Performance Impact|

By enabling earlier detection and treatment of heart failure risk, [...]

What types of patients benefit most from Vivio^® testing?

Ventric Health2026-04-21T19:02:15+00:00March 17, 2026|For Clinicians & Care Teams|

Patients who are at high-risk of heart failure because of [...]

Can Vivio^® be used in a typical primary care workflow?

Ventric Health2026-04-21T19:01:44+00:00March 17, 2026|For Clinicians & Care Teams|

Yes. Vivio® is designed to integrate into routine visits without [...]

Is Vivio^® FDA-cleared?

Ventric Health2026-04-21T16:11:55+00:00March 17, 2026|For Clinicians & Care Teams, Vivio|

Yes. Vivio® received 510(k) clearance from the U.S. Food and [...]

Does Vivio^® replace echocardiography or catheterization?

Ventric Health2026-04-21T19:01:07+00:00March 17, 2026|For Clinicians & Care Teams|

No. Vivio® is designed to identify if patients who are [...]

What exactly does Vivio^® measure?

Ventric Health2026-04-21T19:25:41+00:00March 17, 2026|For Clinicians & Care Teams|

Vivio® indicates whether left ventricular end-diastolic pressure (LVEDP) is elevated, [...]

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