CorVista Health has received FDA clearance for a non‑invasive, AI‑driven add‑on that estimates pulmonary capillary wedge pressure (PCWP), a key measure used when heart failure is suspected. The test analyses a few minutes of resting electrical and hemodynamic signals from symptomatic patients without prior right heart catheterisation to help identify HFrEF and HFpEF. This clearance follows CorVista's earlier FDA approvals for CAD (Sept 2023) and PH (Apr 2024) and comes amid rapid growth in healthcare AI, which GlobalData forecasts to rise from $11.9bn in 2024 to $57.4bn by 2029. The decision also follows AHA findings that AI tools can sometimes detect HFpEF months earlier than routine care.
FDA Clears CorVista AI Add-On to Non‑Invasively Estimate Key Heart‑Failure Pressure (PCWP)
CorVista wins FDA clearance for AI heart failure assessment add-on
The US Food and Drug Administration (FDA) has granted clearance for a new add-on test to CorVista Health's cardiopulmonary diagnostic platform that non‑invasively estimates pulmonary capillary wedge pressure (PCWP), an important marker used when heart failure is suspected.
What the Test Does
PCWP is traditionally estimated invasively via catheterisation to assess left atrial pressure and left ventricular filling pressure. CorVista's newly cleared PCWP test applies artificial intelligence to a few minutes of resting physiological data—electrical and hemodynamic signals—from symptomatic patients who have no known history of elevated PCWP and have not previously undergone right heart catheterisation. The goal is to provide clinicians with additional information to help identify heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF).
Regulatory Context
This clearance builds on prior FDA clearances for CorVista's cardiopulmonary platform addressing coronary artery disease (CAD) (September 2023) and pulmonary hypertension (PH) (April 2024). The PCWP add-on is positioned as an adjunct diagnostic tool to support clinical decision making—not as a replacement for invasive testing when that remains clinically indicated.
Clinical Need
Heart failure affects roughly 7.7 million Americans annually, and HFpEF accounts for about half of those cases. HFpEF can be difficult to diagnose because its symptoms—such as shortness of breath and chest discomfort—are often non‑specific and may not be apparent on standard imaging tests. A non‑invasive tool that flags elevated filling pressures could shorten the diagnostic pathway for many patients and better target invasive testing to those most likely to benefit.
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.
— Adrian Lam, President and Chief Executive Officer, CorVista Health
Broader AI Context
Artificial intelligence is increasingly applied across healthcare. Research firm GlobalData estimated the combined healthcare AI market at $11.9 billion in 2024 and projected growth to $57.4 billion by 2029. The CorVista clearance follows an American Heart Association (AHA) Impact Report highlighting UK‑based Ultromics' EchoGo Heart Failure AI, which the AHA found could identify patients with HFpEF up to nine months earlier than standard care in some cases.
This FDA clearance positions CorVista's PCWP add-on as another non‑invasive AI option aimed at improving early detection and triage of patients with suspected heart‑failure physiology. The tool is intended to augment clinician judgment and help prioritize further testing or treatment.
Original reporting by Medical Device Network, a GlobalData owned brand.
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