US-based medical technology company Ventric Health has received the US Food and Drug Administration (FDA) 510(k) approval for its Vivio System to aid detection of heart failure.
The Vivio system is a portable medical device that helps clinicians to non-invasively diagnose heart failure in both clinical point-of-care and home care settings.
Heart failure is caused when the heart does not pump enough blood to meet the body’s needs, resulting in elevated filling pressure, also known as left ventricular end-diastolic pressure (LVEDP), said the company.
Vivio is designed to reduce the impact of heart failure and delay its progression, allowing healthcare organisations to improve clinical and health outcomes.
It leverages advanced algorithms to rapidly detect elevated LVEDP in a non-invasive manner.
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.”
Ventric Health said that its Vivio system is beneficial for both patients and clinicians and serves as an alternative to traditional methods like catheterisation or echocardiograms.
Building on its adaptability across care settings and real-time results, the system improves the effectiveness of clinical workflow while enabling patient-centric care.
The system also helps overcome social determinants of health (SDOH) barriers to heart failure diagnosis, such as transportation limitations.
In a recent survey of patients, all the respondents found the Vivio test is easier to perform on them, and 95% preferred it over an echocardiogram, said the medical technology company.
Ventric Health co-founder Mory Gharib said: “This is an indispensable clinical insight for clinicians in any care setting.
“It fortifies our commitment to provide transformational clinical interventions in cardiovascular health, enabling clinicians and value-based care organisations to expand the site of care for diagnoses, grow the number of patients that can be reached, and change the timeline for treatment.”
