CorVista wins FDA clearance for AI heart failure assessment add-on

CorVista’s AI-based pulmonary capillary wedge pressure add-on test represents the third FDA clearance for its cardiopulmonary platform.

The US Food and Drug Administration (FDA) has cleared a new add-on test for CorVista Health’s cardiopulmonary diagnostic platform to identify patients with elevated pulmonary capillary wedge pressure (PCWP) – a key indicator of suspected heart failure.

PCWP testing is commonly undertaken via the insertion of a catheter to estimate the pressure inside the heart’s left atrium and the filling pressure of the left ventricle.

CorVista’s PCWP test’s clearance follows its cardiopulmonary platform’s previous FDA clearances for coronary artery disease (CAD) and pulmonary hypertension (PH), which came in September 2023 and April 2024, respectively.

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