Ventric Health & Vivio System FAQs
About Ventric Health
Ventric Health is a Pasadena-based medical technology company focused on improving cardiovascular health by empowering earlier detection of heart failure, especially in primary care settings. It develops non-invasive diagnostic solutions that help clinicians find and intervene in heart disease sooner.
Ventric Health’s mission is to create non-invasive heart diagnostic solutions that quickly deliver actionable insights to reduce care costs and improve patient lives, particularly for value-based care organizations and healthcare teams.
The company aims to bring non-invasive cardiovascular testing to everyone — expanding diagnosis beyond traditional environments and diagnosing patients earlier to improve clinical outcomes.
Ventric was founded in 2014 to commercialize technology developed in the laboratory of the California Institute of Technology based on breakthrough cardiovascular research conducted by Professor Mory Gharib and his postdoctoral fellows Niema Pahlevan and Derek Rinderknecht.
Vivio® — Heart Failure Diagnostic System
Vivio® is Ventric Health’s flagship non-invasive medical device designed to detect elevated left ventricular end-diastolic pressure (LVEDP), the clinical hallmark of heart failure. It can be used in primary care and home health settings.
The Vivio System uses patented advanced hemodynamic algorithms and data measurements to non-invasively indicate elevated LVEDP in under five minutes, giving clinicians real-time results during a standard visit.
Unlike catheterization or echocardiograms, Vivio’s non-invasive design improves accessibility, speed, and ease thus improving patient experience. Because Vivio directly identifies elevated LVEDP it provides a more sensitive measurement and conclusive diagnosis than any other tool available to clinicians in the outpatient setting.
Clinicians can perform the test in under five minutes with results available immediately.
Vivio® has demonstrated high sensitivity and specificity to elevated filling pressures and has been validated in clinical studies for effective early detection of heart failure.
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.
Clinical Impact & Use Cases
Ventric Health was designed to serve primarily clinicians and care teams responsible for at-risk populations, including primary care providers and value-based care organizations looking to identify and manage heart failure earlier within at-risk patient populations.
Heart failure symptoms are often overlooked in routine assessments, and traditional diagnostics can be delayed or inconclusive; catching elevated filling pressure early helps clinicians intervene sooner, improve outcomes and reduce healthcare costs.
Yes — because Vivio® is mobile and non-invasive, trained clinicians can bring the device directly to patients in home health or community settings, overcoming barriers like transportation and access.
The Resources Hub includes clinical articles and validation studies showing Vivio’s effectiveness in different care settings.
Outcomes & Benefits
Practices using Vivio have reported increased early diagnoses especially in the primary care setting, better guideline-directed therapy initiation, decreased hospitalizations and ER visits, and improved medication compliance.
Clinical feedback indicates high patient preference for Vivio compared to traditional diagnostics and ease of administration. Patients appreciate providers’ proactive approach to their heart health.
By enabling earlier detection and treatment of heart failure risk, Vivio® helps reduce avoidable hospitalizations, emergency department visits, and downstream costs associated with late-stage disease. A positive Vivio test – coupled with appropriate chart documentation – allows for the submission of ICD-10 I50.1 which continues to map to HCC 226 under the current CMS RAF-HCC v28 model.
Partnerships & Implementation
Implementation is very straightforward. Care teams interested in Vivio® can request a demo via the Ventric Health website to explore practical implementation approaches within their clinical workflow.
Yes. A key part of the implementation process is to ensure physicians and clinical support staff fully understand how Vivio works, choose the most effective workflow, and can successfully deploy the appropriate treatment processes.
General Website / Legal Questions
The site is intended for users 18 or older and is meant for general information and legitimate business use in connection with Ventric Health’s services.
The Terms of Use restrict reproduction, distribution, and derivative works unless explicitly permitted by the company.
No. The content on the Ventric Health website is for informational purposes only and does not replace professional medical advice.
The site is intended for healthcare professionals, organizations, partners, and individuals seeking information about Ventric Health’s technology and mission.
FAQs for Organization Types & Roles
For Clinicians & Care Teams
Clinicians can perform the test in under five minutes with results available immediately.
Early heart failure symptoms are often non-specific and overlap with common conditions like aging, obesity, or pulmonary disease. Traditional diagnostic tools are expensive, invasive, or not readily available at the point of care, delaying diagnosis and treatment.
Vivio® provides a fast, non-invasive indication of elevated left ventricular filling pressure, the clinical hallmark of heart failure, enabling clinicians to identify heart failure proactively during routine visits.
Vivio® indicates whether left ventricular end-diastolic pressure (LVEDP) is elevated, specifically – >18mmHg, which correlates with worsening cardiac function and heart failure.
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.
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.
Yes. Vivio® is designed to integrate into routine visits without disrupting patient flow or requiring specialized facilities.
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.
For Value-Based Care Organizations & Health Systems
By enabling earlier detection and treatment of heart failure risk, Vivio® helps reduce avoidable hospitalizations, emergency department visits, and downstream costs associated with late-stage disease. A positive Vivio test – coupled with appropriate chart documentation – allows for the submission of ICD-10 I50.1 which continues to map to HCC 226 under the current CMS RAF-HCC v28 model.
Vivio® supports management of large at-risk populations where heart failure is underdiagnosed, particularly among aging patients and those with multiple chronic conditions.
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.
For Home Health & Community-Based Care Teams
Yes — because Vivio® is mobile and non-invasive, trained clinicians can bring the device directly to patients in home health or community settings, overcoming barriers like transportation and access.
Yes. Vivio® is mobile and non-invasive, making it suitable for home visits, community clinics, and post-acute care settings.
By bringing advanced cardiovascular assessment directly to the patient, Vivio® reduces barriers such as access to transportation, scheduling delays, and referral bottlenecks.
For Patients & Caregivers
The Vivio® test is quick, non-invasive and painless. Patients report that the test was easy and are appreciative to have Vivio completed during a routine primary care visit.
An elevated result suggests increased pressure in the heart, which may indicate early or worsening heart failure. Your clinician will use this information to guide next steps.
Vivio® allows clinicians to identify potential heart problems earlier — often before symptoms are recognized or become severe — so treatment or referrals can begin sooner.
Vivio® helps your primary care physician determine whether further cardiac evaluation may be needed and supports timely referral when appropriate. The Vivio System helps to identify the right patients to send to cardiology.
A positive Vivio test result indicates that the filling pressure in your heart’s left ventricle is elevated to the point where damage to your heart can occur. This finding demonstrates you are in the initial stage of heart failure. Your clinician will use this information alongside symptomatology to guide next steps.
For Partners, Investors & Industry Stakeholders
Ventric Health focuses on non-invasive, point-of-care solutions that extend advanced cardiovascular insights into primary care and community settings where most patients are first seen. Ventric Health’s Vivio System is the first and only FDA-cleared medical device available that can non-invasively identify elevated LVEDP – the clinical hallmark of heart failure.
The underdiagnosis and delayed diagnosis of heart failure, which contributes to patient suffering, poor outcomes and high healthcare costs.
To make advanced, non-invasive cardiovascular assessment accessible to everyone, enabling earlier intervention and better outcomes across the care continuum.
Implementation & Customer Service FAQs
Getting Started & Implementation – For customers onboarding or expanding use
The Ventric implementation team leads the customer through a short discovery meeting to review the necessary workflow decisions (clinical, operational and applications/EMR related) as well as any applications setup that will need to be completed prior to pilot Go Live. These decisions are integrated into educational materials, ensuring all stakeholders understand Vivio’s importance to patient care and the goals for integrating this new diagnostic tool into the workflow
Pilot sites can generally be activated in 4-6 weeks after initiating the implementation process.
Our Clinical Implementation team will be onsite during go-live to perform hands on training and to support questions with first Live patient use. They are supported by our implementation team, Service Account Managers, and IT team remotely.
The most successful rollouts occur when provider groups develop a communication plan ensuring all stakeholders understand Vivio’s importance to patient care and the goals for integrating this new diagnostic tool into the workflow. Ventric’s implementation team will support this process with templates, suggested topics and subject matter experts in cardiology and on the Vivio system.
Clinical Workflow & Day-to-Day Use – For clinicians and care teams using Vivio regularly
Generally the test is conducted by a Medical Assistant or Nurse as the patient is being roomed and vitals collected. Vivio can be incorporated into existing visit types with current staff (Office visit, AWV or Wellness Clinic), or alternatively conducted through a Heart Health Clinic – screening visit, which has demonstrated to be effective at ensuring consistency in eligible patients receiving the test and limiting user error.
Vivio tests are conducted in under five minutes during the visit. After a positive test, the user is also prompted to conduct the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) assessment. KCCQ-12 is a commonly used tool to evaluate the health status of patients with heart failure
During the implementation, the customer’s medical leadership will determine the characteristics of the at-risk population that will be tested. Patients with existing conditions (e.g. diabetes, CKD, COPD, obesity, hypertension) who are at risk for structural heart changes but have no current abnormality should be tested with Vivio.
Together with the KCCQ-12, the Vivio test results allow clinicians to assess the current and longitudinal health status of heart failure patients and help determine who can be managed in the primary care setting and who may benefit from specialty referral.
As part of the implementation process, the customer will determine the clinical workflow for patients after a positive Vivio is received, including how patients will be stratified and what the treatment plan, monitoring, and escalation path will be. Clinical leaders often use the KCCQ to stratify the patient population after a positive Vivio and develop protocols based on their patient population and resource support.
Technology, Devices & System Access – For operational and IT stakeholders
Ventric Health provides the Vivio System and iPad as part of the licensing agreement. Ventric also provides a starter supply of snap electrodes, and the customer is responsible for purchasing additional electrodes on an ongoing basis.
The Vivio System App is developed in house with vigorous QA and Verification & Processes applied before Apple Beta Review and Approval Submission is executed. The Company distributes all App updates via a Zoho MDM platform which uses a Custom App Store mechanism for private device distribution along with App and hardware security control profile configurations.
In case of an issue with use of a device, the customer will contact Ventric’s Customer Support team (support@ventrichealth.com) to initiate troubleshooting.
Data, Reporting & Integration – For clinical leadership, quality teams, and analytics users
All patient heart sound and pulse waveform data is created through the EKG Patch and Cuff, synched by timestamp and then sent through an encrypted bluetooth tunnel where it is sent to the Vivio App on an iPad Mini. The data is converted in JSON nodes along with other patient centric data (PHI encrypted) collected via the App, transported via encrypted Lambda services and stored in AWS s3 locations based upon Customer unique signature configurations.
Ventric offers a Vivio-EHR integration package through Redox, a commercial intermediary platform that specializes in EHR integration. Redox supports posting Vivio results to the EHR encounter, as well as matching MRN/DOB and pulling patient name into Vivio from the EHR.
Ventric provides regular detailed reporting of conclusive and inconclusive tests, which are delivered via sFTP. In addition, operational reports detailing volume trending and user errors will be provided regularly, as will a Heart Failure Snapshot for the clinical leaders that highlights distribution of KCCQ-12 scores as well as patient characteristics and positivity rate.
Vivio supports population-level risk stratification in two ways. First, for patients with risk factors, Vivio diagnoses elevated filling pressures or heart failure before symptoms escalate and land the patient in the ER/in-patient setting. Second, Vivio combines the results of its test with the Kansas City Cardiomyopathy Questionnaire (KCCQ-12), which allows physicians to triage patients with heart failure from lower risk/lower symptomatology to high risk/high symptomatology. This triaging workflow ensures patients who need more advanced speciality care receive a timely referral before experiencing an acute utilization.
Compliance, Privacy & Security – For compliance officers and administrators
All Vivio products and associated infrastructure are processed through Regulatory and Quality Assurance mechanisms that adhere to HIPAA standards & requirements. All Ventric Health Employees are trained on HIPAA requirements yearly to ensure best practices are used when handling PHI information
Patient data is protected using strong encryption both in transit and at rest. All data transmitted between systems uses modern TLS protocols (TLS 1.2 and TLS 1.3) with current cipher suites such as AES-256-GCM and ECDHE for forward secrecy, while stored data is encrypted using AES-256. Access to patient data is governed by role-based access control (RBAC) enforcing least-privilege access, and data is logically segmented by customer to prevent cross-tenant exposure. Security controls, access activity, and operational processes are independently reviewed through annual SOC 2 and HITRUST e1 compliance assessments to verify that appropriate safeguards remain in place.
Vivio is FDA cleared as a Class II Medical Device.
Following each test, clinicians receive a Vivio report that contains the essential items needed to ensure compliant documentation. Vivio® test results integrate well into commonly used documentation approaches (e.g. M.E.A.T or D.S.P). Independent third-party reviews of Vivio® support its use in assigning ICD-10 code I50.1 left ventricular failure for patients with a positive Vivio result.
Ventric provides regular detailed reporting of conclusive and inconclusive tests, which can be delivered via SFTP. In addition, operational reports detailing volume trending and user errors will be provided regularly, as will a Heart Failure Snapshot that highlights distribution of KCCQ-12 scores as well as patient characteristics and positivity rate.
Value-Based Care & Performance Impact – For executives and value-based care leaders
By enabling earlier detection and treatment of heart failure risk, Vivio® helps reduce avoidable hospitalizations, emergency department visits, and downstream costs associated with late-stage disease. A positive Vivio test – coupled with appropriate chart documentation – allows for the submission of ICD-10 I50.1 which continues to map to HCC 226 under the current CMS RAF-HCC v28 model.
Ventric partners with customers to review volume trends at the practice and provider level to evaluate those engaged with the device and identify opportunities to re-educate. Ventric also reviews error rates to understand if additional user-level training is beneficial to reduce controllable errors (inconclusive).
Vivio is identifying patients who, without intervention, will end up requiring acute care utilization. By avoiding this utilization, provider groups are improving patient experience and outcomes while reducing medical expense.
Heart Failure is a leading cause of hospitalization, mortality and healthcare cost. Vivio allows providers to proactively identify patients who have heart failure and intervene to change the patients’ outcomes.
Provider groups look at ROI from both 1) how the diagnosis of heart failure supports the additional care and resources that will be needed financially to manage these patients as well as 2) the downstream utilization avoidance.
Training, Education & Ongoing Support – For all customer roles
Our Clinical Implementation team will be onsite during go-live to perform hands on training and to support questions with first Live patient use. They are supported by our implementation team, Service Account Managers, and IT team remotely.
Ventric’s team provides the training materials for provider and end user training, as well as physical training binders to be left onsite, and links to videos to support questions. Trainers will be at the practice to support end-users as they initiate using the Vivio with their patients. In addition, the customer has access to Ventric’s support and customer success teams to answer questions.
Refresher and new user training can be offered virtually at any time, and onsite if needed. We also recommend identifying a super-user at each location who can be trained to respond to common questions, as well as serve as a resource for local workflow/EHR questions.
Customers send an email to support@ventrichealth.com to ask a question, initiate a service ticket, or submit a feature request.
Troubleshooting & Customer Support – For immediate operational needs
Please send an email to support@ventrichealth.com to initiate a service ticket.
Ventric Health’s Field Operations and IT teams will address support requests according to the priority of the request and use commercially reasonable efforts to respond to high priority requests within 1 business day for high priority topics, and 3 business days for medium priority requests, with lower priority within a commercially reasonable time frame.
Customers are provided with a Service Account Manager (SAM). Please log a ticket via support@ventrichealth.com and also reach out to your SAM for urgent issues.
Scaling, Expansion & Optimization – For mature customers looking to grow usage
Yes — because Vivio® is mobile and non-invasive, trained clinicians can bring the device directly to patients in home health or community settings, overcoming barriers like transportation and access.
You will be assigned a Service Account Manager, and expansion to additional sites or providers can be planned through this channel.
We have found that the following three practices are key in implementation: 1) Identify highly engaged groups or practices to serve as pilot sites, 2) Thoughtfully develop clinical and operational workflows that integrate seamlessly into existing processes, 3) Establish a clear communication strategy so providers and care teams understand the patient impact of using the device.
Ventric continues to partner with you after go-live to ensure smooth handoff from implementation to stable adoption. Volume and error rates are regularly reviewed with operators to identify opportunities for re-education. Regular touchpoints with Medical Leadership and Operators support engagement efforts with providers by reviewing volumes at the provider/practice level, evaluating the KCCQ findings and the opportunity to highlight best practices and new clinical
