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Heart failure remains one of the leading causes of illness and death worldwide, yet diagnosing certain forms of the condition continues to be a challenge. Patients with symptoms such as chest pain, shortness of breath, and fatigue often require multiple tests before receiving a diagnosis, particularly when clinicians suspect heart failure with preserved ejection fraction (HFpEF).
CorVista Health and Analytics For Life have announced that the U.S. Food and Drug Administration (FDA) has cleared the CorVista® System Pulmonary Capillary Wedge Pressure (PCWP) Add-On, introducing a new noninvasive tool that helps healthcare providers assess the likelihood of elevated pulmonary capillary wedge pressure (PCWP). The clearance expands the capabilities of the CorVista System and aims to support earlier diagnosis of heart failure and pulmonary hypertension.
The newly cleared PCWP Add-On uses an AI-based algorithm to analyse physiological signals collected from patients presenting with cardiovascular symptoms who have no previous history of elevated PCWP or prior right heart catheterisation.
The technology is designed to identify the likelihood of elevated pulmonary capillary wedge pressure, an important clinical marker associated with both:
Rather than replacing clinical judgement, the system provides additional diagnostic information that clinicians can consider alongside a patient’s symptoms, medical history, and other clinical findings.
Pulmonary capillary wedge pressure is an important measurement used to evaluate pressure within the left side of the heart. Elevated PCWP can indicate heart failure and several forms of pulmonary hypertension.
Traditionally, measuring PCWP requires right heart catheterisation—an invasive procedure performed in specialised clinical settings. By providing a noninvasive assessment, the CorVista System may help clinicians identify patients who could benefit from earlier intervention while potentially reducing the need for invasive testing in some cases.
Heart failure affects an estimated 7.7 million adults in the United States, with nearly 90,000 deaths attributed to the condition in 2023. Despite accounting for approximately half of all heart failure cases, HFpEF remains underdiagnosed because its symptoms often overlap with other cardiovascular conditions.
The CorVista System Capture device performs a 3.5-minute resting acquisition, collecting electrical and haemodynamic signals from the patient without invasive procedures.
Using AI-based analysis, the platform processes these physiological signals and produces a binary result indicating the likelihood of elevated PCWP.
The output is intended to assist healthcare providers as part of a broader clinical evaluation rather than serving as a standalone diagnosis.
Charles R. Bridges, M.D., Sc.D., Executive Vice President and Chief Scientific Officer at CorVista Health and Analytics For Life, said the FDA clearance reflects the company’s ongoing efforts to improve cardiopulmonary diagnostics.
He noted that noninvasive PCWP assessment could help patients with HFpEF, HFrEF, and pulmonary hypertension receive earlier diagnoses and appropriate treatment while potentially avoiding unnecessary invasive procedures.
Adrian Lam, President and Chief Executive Officer of CorVista Health, added that many patients with suspected heart failure still face lengthy diagnostic journeys, particularly those with HFpEF. He said the expanded capabilities of the CorVista System support evaluation across conditions affecting a significant proportion of patients with symptomatic cardiovascular disease.
The latest clearance adds to the CorVista System’s growing list of regulatory milestones.
The platform previously received FDA clearance for:
In 2022, the system’s pulmonary hypertension indication also received FDA Breakthrough Device Designation.
Beginning 1 January 2027, the new Category III CPT code 1104T will support reporting for use of the CorVista System in evaluating coronary artery disease, pulmonary hypertension, and elevated PCWP using augmentative algorithmic analysis of orthogonal voltage gradient and photoplethysmography signals.
The FDA clearance represents another step in the growing adoption of AI-assisted diagnostic tools in cardiovascular care. By combining sensor-acquired physiological signals with machine learning algorithms, platforms such as the CorVista System aim to provide clinicians with additional decision-support tools at the point of care.
As healthcare systems continue to prioritise earlier diagnosis, improved patient pathways, and reduced reliance on invasive procedures where appropriate, noninvasive AI-powered technologies are expected to play an increasingly important role in cardiovascular disease assessment.
Want to explore how AI, digital diagnostics, and cardiovascular innovation are changing healthcare delivery across Asia-Pacific? Join the conversation at MedTech World Asia 2026, taking place in Hong Kong from 26 to 28 August, where global leaders will discuss the latest advances in digital health, AI-powered diagnostics, and emerging medical technologies. Adrian Lam, President and Chief Executive Officer of CorVista Health, will also join the panel, “Why Hong Kong? The Strategic Gateway to Asia’s MedTech Ecosystem,” to share insights on the region’s growing role in MedTech innovation and market expansion. Explore the agenda and book your spot now.
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