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.
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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.
The company’s non-invasive PCWP test uses AI to analyse physiological signals from patients with no history of elevated PCWP or prior right heart catheterisation who present with cardiovascular symptoms including chest pain and shortness of breath. By collecting electrical and haemodynamic signals over a few minutes of rest, the test is intended to provide clinicians with additional information to assist in the diagnosis of heart failure with reduced ejection fraction and preserved ejection fraction (HFrEF/HFpEF).
Heart failure affects approximately 7.7 million Americans annually, with HFpEF accounting for around half of all heart failure cases. However, the condition remains underdiagnosed given that its symptoms tend to be non-specific and may not show up on standard imaging tests.
CorVista’s president and CEO, Adrian Lam, commented: “For millions of people with suspected heart failure, the path to a clear answer is still too long – HFpEF, one of the most common forms, remains difficult to identify without invasive testing.
“With this clearance, the CorVista System supports assessment across conditions that account for up to 75% of people with symptomatic cardiovascular disease.”
AI is having a vast impact in healthcare, with the combined AI market across the sector valued at $11.9bn in 2024 and projected to reach a valuation of $57.4bn in 2029, according to a report by GlobalData.
CorVista’s FDA clearance follows the publication of a report by the American Heart Association (AHA) that highlighted the benefits of UK-based Ultromics’ EchoGo Heart Failure AI algorithm in the earlier identification of patients with HFpEF. The AHA’s Impact Report found that Ultromics’ AI tool could identify patients with HFpEF up to nine months earlier than standard clinical care.
