News | Heart Failure | August 15, 2025

Clinical Study Examines Non-Invasive Point-of-Care Test for Elevated PCWP Using Machine Learning

Study achieves primary sensitivity endpoint, advancing diagnostics for heart failure with preserved ejection fraction (HFpEF) and pulmonary hypertension (PH)


Aug. 14, 2025 — Analytics For Life, in collaboration with its U.S. commercial partner CorVista Health, announced they have successfully completed the clinical study evaluating a machine learning-based algorithm for non-invasively identifying patients with elevated pulmonary capillary wedge pressure (PCWP) – a key indicator of both heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF). The study met its primary endpoint for sensitivity, marking a significant milestone in the advancement in point-of-care diagnostics for heart failure patients. The results of the study will be submitted for peer-reviewed publication and presented at an upcoming scientific conference.

Currently, PCWP is measured through an invasive right heart catheterization (iRHC) procedure, typically performed by a cardiologist, pulmonologist or intensivist. The CorVista capture device collects non-invasive signals for 3.5 minutes in patients at rest, potentially providing a novel method to aid in the assessment of patients being evaluated for pulmonary hypertension or heart failure.

“Reaching our primary endpoint in sensitivity is a testament to the dedication of our team to pushing the boundaries of cardiovascular diagnostics. Our ability to deliver non-invasive, rapid assessment of PCWP could be a game-changer, making early detection of HFpEF, HFrEF and PH subtypes more accessible for patients,” said Charles R. Bridges, M.D., Sc.D., Executive Vice President and Chief Scientific Officer, Analytics for Life and CorVista Health. “With the clinical study now complete, we plan to initiate dialogue with regulatory agencies in preparation for the next phase of development.”

Adrian Lam, President and Chief Executive Officer, CorVista Health, added, “This milestone demonstrates the power of our rapid, point-of-care solution and represents an important step toward expanding the clinical utility of the CorVista System. Adding PCWP and heart failure capabilities would allow our system to provide diagnostic support to more than 70% of all people with symptomatic cardiovascular disease – itself the leading cause of death worldwide. As we pursue a PCWP add-on, our goal is to bring advanced diagnostic accuracy into the primary care setting, enabling faster and more accurate treatment decisions while reducing the overall cost of care.”

HFpEF accounts for over 50% of all heart failure cases and carries the highest rates of morbidity and mortality. Underdiagnosis of HFpEF remains one of the greatest unmet needs in cardiovascular medicine today, contributing an estimated $25 billion in direct costs to the U.S. healthcare system each year. Pulmonary hypertension, similarly underdiagnosed, requires accurate subtype classification to guide life-saving, guideline-directed therapy.

The proposed PCWP add-on represents a major advancement in cardiology with far-reaching implications for early diagnosis, equitable care, and cost reduction. The CorVista System Add-On for elevated PCWP is currently an investigational device, limited by U.S. federal law to investigational use and not commercially available.

For more information on Analytics For Life, please visit: www.analytics4life.com or www.corvista.com


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