FDA Clears CorVista® System PCWP Add-On as a Noninvasive Test For Elevated Pulmonary Capillary Wedge Pressure

• The PCWP Add-On represents the third FDA clearance for the CorVista System, a novel cardiopulmonary platform used at the point of care
• Elevated pulmonary capillary wedge pressure (PCWP) is a key indicator of both heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF)
• The PCWP Add-On integrates into the existing CorVista System, currently marketed in the U.S. as an aid in diagnosis for pulmonary hypertension (PH) and coronary artery disease (CAD)

BETHESDA, Md. & TORONTO--(BUSINESS WIRE)--CorVista Health and Analytics For Life today announced FDA clearance of the CorVista® System with Pulmonary Capillary Wedge Pressure (PCWP) Add-On. The PCWP Add-On uses an AI-based algorithm to analyze physiological signals from patients with no history of elevated PCWP or prior right heart catheterization presenting with cardiovascular symptoms, such as chest pain, dyspnea, and fatigue, to indicate the likelihood of elevated PCWP. The clearance marks a key expansion of CorVista’s growing diagnostic platform, enabling healthcare providers to noninvasively identify patients with likely elevated pulmonary capillary wedge pressure (PCWP) — a key indicator of both HFpEF and HFrEF.

Heart failure affects an estimated 7.7 million U.S. adults and was the underlying cause of nearly 90,000 deaths in 2023. Although heart failure with preserved ejection fraction (HFpEF) accounts for about half of all heart failure cases, it remains under-diagnosed — leading to delays in care and increased costs for patients and the broader healthcare system.

“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, M.D., Sc.D., 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.”

The CorVista System Capture device noninvasively collects electrical and hemodynamic signals during a 3.5-minute resting acquisition. The CorVista System analyzes those signals to provide a binary output and indicate the likelihood of elevated PCWP, providing healthcare providers with additional information to interpret alongside their clinical judgment and the patient’s signs, symptoms and clinical history as an aid in diagnosis.

Adrian Lam, President and Chief Executive Officer, CorVista Health, added, “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.”

The PCWP Add-On represents a major advancement in cardiology with the potential for far-reaching implications for early diagnosis, equitable care, and cost reduction.

Sources

American College of Cardiology. (2025, June 1). Focus on heart failure | HFpEF: Where we stand in 2025

Borlaug, B. A., et. al. (2023). Heart failure with preserved ejection fraction: JACC scientific statement. Journal of the American College of Cardiology, 81(18), 1810–1834.

Desai, A. S., et. al. (2023). How to manage heart failure with preserved ejection fraction: Practical guidance for clinicians. JACC: Heart Failure, 11(6), 619–636.

Palaniappan, L. P., et. al. (2026). Heart disease and stroke statistics—2026 update: A report of US and global data from the American Heart Association. Circulation, 153(9), e275–e906

Redfield, M. M., & Borlaug, B. A. (2023). Heart failure with preserved ejection fraction: A review. JAMA, 329(10), 827–838.

About the CorVista® System

Developed and manufactured by Analytics For Life and commercialized in the U.S. by CorVista Health, the CorVista® System is a point-of-care digital health platform that analyzes sensor-acquired physiological signals to indicate the likelihood of specified cardiovascular conditions, including significant coronary artery disease, elevated mean pulmonary arterial pressure, and elevated pulmonary capillary wedge pressure. Results are presented for interpretation by healthcare providers in conjunction with clinical judgment and the patient's signs, symptoms, and clinical history as an aid in diagnosis. The system received FDA clearance for coronary artery disease in September 2023, pulmonary hypertension in April 2024, and elevated PCWP in July 2026. In 2022, the CorVista System's pulmonary hypertension indication received FDA Breakthrough Device Designation.

Category III CPT code, 1104T, will become effective Jan. 1, 2027, and will support reporting for the use of the CorVista System in the assessment of potential CAD, PH, and elevated PCWP using augmentative algorithmic analysis of orthogonal voltage gradient and photoplethysmography signals.

About Analytics For Life

Analytics For Life develops digital health technologies for point-of-care cardiovascular diagnostics. The company developed and manufactures the CorVista® System, a noninvasive platform that uses sensor-acquired physiological signals and AI-based algorithms to support clinical assessment.

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

About CorVista Health

CorVista Health is on a mission to transform cardiovascular care with diagnostics that shorten the path from symptoms to diagnosis, empowering earlier treatment and better patient outcomes.

For more information on CorVista Health, please visit: www.corvista.com