CorVista System Receives FDA Clearance for Noninvasive PCWP Test

The US Food and Drug Administration (FDA) has cleared CorVista Health's Pulmonary Capillary Wedge Pressure (PCWP) Add-On for the CorVista System, an artificial intelligence-based tool designed to noninvasively indicate the likelihood of elevated PCWP in patients presenting with cardiovascular symptoms.¹

The Add-On analyzes physiologic signals in patients with no history of elevated PCWP or prior right heart catheterization who present with symptoms such as chest pain, dyspnea, or fatigue. The clearance expands CorVista's diagnostic platform to include a marker relevant to both heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF).

Heart failure affects an estimated 7.7 million adults in the United States and was the underlying cause of nearly 90,000 deaths in 2023.² HFpEF accounts for about half of heart failure cases yet remains underdiagnosed, contributing to delays in care and added costs across the healthcare system. Elevated PCWP is a hemodynamic marker for both HFpEF and HFrEF, and identifying it typically has required invasive right heart catheterization.

“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 — advancing our mission to improve access to lifesaving care,” Adrian Lam, President and Chief Executive Officer, CorVista Health, said in a statement.

How the CorVista System PCWP Add-On Works

The CorVista System Capture device collects electrical and hemodynamic signals noninvasively during a resting acquisition lasting three and a half minutes, according to the company. An AI-based algorithm analyzes these signals and generates a binary output indicating the likelihood of elevated PCWP, intended for use alongside clinical judgment and a patient's signs, symptoms, and history rather than as a standalone diagnostic.

The PCWP Add-On is intended for patients with no prior history of elevated PCWP or right heart catheterization who present with cardiovascular symptoms such as chest pain, dyspnea, or fatigue, per CorVista Health. The company positions the tool as an option for clinicians evaluating patients for heart failure or pulmonary hypertension before proceeding to invasive testing.

Clinical Significance for HFpEF and Pulmonary Hypertension

The company positions the PCWP Add-On as a way for clinicians evaluating patients for heart failure or pulmonary hypertension to avoid unnecessary invasive testing and reach treatment decisions more quickly. The company's announcement did not include specific sensitivity, specificity, or validation cohort data supporting the clearance.

“This FDA clearance is a testament to the dedication of our team to pushing the boundaries of cardiopulmonary diagnostics. By delivering a noninvasive assessment of PCWP, we can help patients with HFpEF, HFrEF and PH subtypes reach an earlier, more accurate diagnosis — and get to the appropriate treatment sooner,” said Charles R. Bridges, MD, ScD, Executive Vice President and Chief Scientific Officer, CorVista Health and Analytics For Life. “With this clearance, patients being evaluated for heart failure or pulmonary hypertension may avoid unnecessary invasive testing and benefit from faster, more confident care decisions and effective treatment.”

References:

1. CorVista Health, Analytics For Life. FDA clears CorVista System PCWP Add-On as a noninvasive test for elevated pulmonary capillary wedge pressure. Published July 28, 2026. Accessed July 28, 2026. https://www.businesswire.com/news/home/20260728250128/en/FDA-Clears-CorVista-System-PCWP-Add-On-as-a-Noninvasive-Test-For-Elevated-Pulmonary-Capillary-Wedge-Pressure

2. Centers for Disease Control and Prevention. Heart failure. Accessed July 28, 2026. https://www.cdc.gov/heart-disease/about/heart-failure.html