Sam Brusco, Associate Editor10.26.23
Ventric Health, a cardiovascular health company, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Vivio system to non-invasively diagnose heart failure in both clinical and home environments.
Vivio is a mobile, tech-enabled device to aid in heart failure diagnosis via advanced algorithms to quickly spot elevated left ventricular and diastolic pressure (LVEDP) non-invasively.
"Up to 50% of heart failure patients are undiagnosed, and diagnosis can lag up to 30 months following the initial onset of symptoms," Ventric co-founder and CEO Sean Brady told the press. "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."
Vivio’s mobility and simplicity, according to the company, 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. A recent survey of patients showed all respondents found the Vivio test easy to have clinicians perform on them and 95% preferred it to receiving an echocardiogram.
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 organizations to expand the site of care for diagnoses, grow the number of patients that can be reached, and change the timeline for treatment."
Vivio is a mobile, tech-enabled device to aid in heart failure diagnosis via advanced algorithms to quickly spot elevated left ventricular and diastolic pressure (LVEDP) non-invasively.
"Up to 50% of heart failure patients are undiagnosed, and diagnosis can lag up to 30 months following the initial onset of symptoms," Ventric co-founder and CEO Sean Brady told the press. "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."
Vivio’s mobility and simplicity, according to the company, 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. A recent survey of patients showed all respondents found the Vivio test easy to have clinicians perform on them and 95% preferred it to receiving an echocardiogram.
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 organizations to expand the site of care for diagnoses, grow the number of patients that can be reached, and change the timeline for treatment."