FDA Clears CorVista® System PCWP Add-On as a Noninvasive Test For Elevated Pulmonary Capillary Wedge Pressure
The PCWP Add-On represents the third FDA clearance for the CorVista System, a novel cardiopulmonary platform used at the point of care Elevated pulmonary capillary wedge pressure (PCWP) is a key indicator of both heart failure with preserved ejection fraction (HFpEF) and heart fa
BETHESDA, Md. & TORONTO -- CorVista Health and Analytics For Life today announced FDA clearance of the CorVista® System with Pulmonary Capillary Wedge Pressure (PCWP) Add-On. The PCWP Add-On uses an AI-based algorithm to analyze physiological signals from patients with no history of elevated PCWP or prior right heart catheterization presenting with cardiovascular symptoms, such as chest pain, dyspnea, and fatigue, to indicate the likelihood of elevated PCWP.
The clearance marks a key expansion of CorVista’s growing diagnostic platform, enabling healthcare providers to noninvasively identify patients with likely elevated pulmonary capillary wedge pressure (PCWP) — a key indicator of both HFpEF and HFrEF. Read More
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