Products

CorVista System with PH Add-On
CorVista Health
Cardiology AI
The CorVista System with PH Add-On is an FDA-cleared, non-invasive, point-of-care AI diagnostic platform for rapid assessment of coronary artery disease and pulmonary hypertension using machine-learned algorithms.

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About CorVista Health

CorVista Health is a digital health company that has developed the CorVista System, an innovative, non-invasive point-of-care diagnostic platform designed to rapidly detect cardiovascular disease. Operating on a medical-device-as-a-service model, the system utilizes a handheld device to capture naturally emitted cardiac and hemodynamic signals from a patient at rest. These physiological measurements are securely transmitted to a cloud-based database where proprietary, machine-learned algorithms analyze the data and deliver a clinical summary within minutes.

For physicians, this technology offers a front-line diagnostic tool to rule out significant coronary artery disease (CAD) with a high negative predictive value, as well as to identify pulmonary hypertension (PH) and signs of heart failure. Because the test is performed at rest and requires no fasting, radiation, contrast agents, or cardiac stress, it significantly mitigates patient risk and streamlines the diagnostic pathway. The rapid turnaround of results during the same clinical visit enables immediate, informed decision-making regarding patient care and downstream testing.

By eliminating the need for capital-intensive imaging equipment or specialized infrastructure, the CorVista System is particularly suited for low-resource, rural, and underserved clinical settings. This allows primary care physicians and clinics to extend high-quality cardiovascular assessments to populations that otherwise face barriers to specialist care, thereby advancing health equity and improving early disease detection.

Focus Areas

cardiovascular disease diagnosis coronary artery disease pulmonary hypertension heart failure artificial intelligence machine learning non-invasive diagnostics point-of-care testing digital health

Business Intelligence

TechnologyCloud-based AI/ML algorithms, portable hardware for physiological signal collection

What Physicians Need to Know

Specialization
CorVista Health specializes in non-invasive, point-of-care cardiovascular diagnostics using AI and machine learning. Their CorVista System is designed to detect conditions like coronary artery disease (CAD), pulmonary hypertension (PH), and heart failure with preserved ejection fraction (HFpEF).
Key Differentiators
Their system offers rapid, non-invasive diagnosis at the point of care, eliminating the need for radiation, contrast agents, injections, fasting, or exercise. It provides results within minutes, enabling quicker treatment decisions. CorVista also utilizes a 'MedTech-as-a-Service' model, bundling their digital health package with cloud service connectivity and validated AI algorithms.
Technology Stack
CorVista's technology stack includes supervised machine learning for diagnostic classification and regression, orthogonal voltage gradient (OVG) signal acquisition, photoplethysmography (PPG), cloud-based signal processing, and secure web portal delivery. They also employ feature engineering and statistical biomarker analysis, non-invasive hemodynamic estimation algorithms, and internet-deployable point-of-care capture devices.
Accessibility & Equity
The portable, iPad-sized CorVista System can extend cardiology services to underserved and rural areas, as it only requires a Wi-Fi or cellular signal. This addresses health equity by providing access to high-quality cardiovascular diagnostics in low-resource settings.
FDA Clearances & Designations
The CorVista System with CAD Add-On has received FDA 510(k) clearance for evaluating significant coronary artery disease. The Pulmonary Hypertension (PH) Add-On has also received FDA clearance and was designated as a Breakthrough Device. An add-on for elevated pulmonary capillary wedge pressure (PCWP) is currently under FDA review.
Physician Tip

For physicians, CorVista Health's system offers a significant advantage by providing rapid, non-invasive, point-of-care diagnostics for cardiovascular conditions like CAD and PH. This can lead to quicker diagnoses and treatment decisions, reducing the need for immediate referrals to specialists or invasive procedures. The system's ease of use and portability make it suitable for various clinical settings, including local physician offices, clinics, and even underserved areas, improving patient access to advanced cardiac care. The detailed diagnostic reports, available in a secure web portal, aid in guiding therapy and improving patient outcomes. The new AMA Category III CPTu00ae code (1104T, effective Jan. 1, 2027) also supports reporting for the use of the CorVista System, which may facilitate reimbursement pathways.

The CorVista System is designed as a platform device with a base system that allows for integration with indication-specific 'Add-Ons' for various diseases. It utilizes cloud-based services for secure storage of patient data and application of its FDA-validated algorithms, with diagnostic reports automatically pushed back to the doctor's office. The system's internet-deployable nature, requiring only a Wi-Fi or cellular signal, highlights its inherent connectivity and potential for seamless integration into existing digital health infrastructures.

Products by CorVista Health

1 product in the directory

CorVista System with PH Add-On
CorVista Health
Cardiology AI
The CorVista System with PH Add-On is an FDA-cleared, non-invasive, point-of-care AI diagnostic platform for rapid assessment of coronary artery disease and pulmonary hypertension using machine-learned algorithms.

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News, demos, and interviews about CorVista Health.

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Press & Coverage

Patient Care Online
CorVista System Receives FDA Clearance for Noninvasive PCWP Test
The FDA has cleared CorVista Health's Pulmonary Capillary Wedge Pressure (PCWP) Add-On for the CorVista System, an AI-based tool for noninvasively indicating the likelihood of elevated PCWP in patients with cardiovascular symptoms. This 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).
2026-07
MedTech World
FDA Clears CorVista System PCWP add-on, expanding AI-powered noninvasive heart failure assessment
CorVista Health and Analytics For Life announced FDA clearance of the CorVista System Pulmonary Capillary Wedge Pressure (PCWP) Add-On, a new noninvasive tool to help assess the likelihood of elevated PCWP. This clearance expands the CorVista System's capabilities and aims to support earlier diagnosis of heart failure and pulmonary hypertension.
2026-07
Medical Product Outsourcing (MPO)
CorVista Health, Mayo Clinic Advance Next-Gen Pulmonary Hypertension Diagnostics
CorVista Health Inc. announced a research collaboration with Mayo Clinic to evaluate how next-generation, non-invasive diagnostics may transform the identification and management of pulmonary hypertension (PH). The collaboration will assess if the FDA-cleared CorVista-PH test can improve how physicians identify and evaluate PH earlier.
2026-07
Business Wire
CorVista Health Announces New AMA Category III CPTu00ae Code for Augmentative AI Analysis of Cardiopulmonary Disease
CorVista Health announced that the American Medical Association (AMA) has granted a new Category III Current Procedural Terminology (CPTu00ae) code for augmentative AI algorithmic analysis of potential coronary artery disease (CAD), pulmonary hypertension (PH), and elevated pulmonary capillary wedge pressure (PCWP). This new code encompasses the FDA-cleared CorVistau00ae System for CAD and PH, as well as the anticipated PCWP Add-On algorithm.
2026-07
Medical Product Outsourcing (MPO)
CorVista Health Welcomes New Member to its Executive Management Team
CorVista Health appointed Nikki Troiano Gainey as Chief Customer Officer and Ian Shadforth as Chief Strategy Officer. These appointments coincide with the company's efforts to advance the commercialization of its AI-enabled, non-invasive cardiovascular testing platform.
2026-08
Pulmonary Hypertension News
Corvista point-of-care device good at detecting heart failure: Study
A study found that Corvista Health's point-of-care device, used to predict pulmonary hypertension, also appears effective at identifying heart failure by accurately detecting elevated pulmonary capillary wedge pressure (PCWP). The machine learning algorithm showed a diagnostic odds ratio of 29, indicating a patient with heart failure was 29 times more likely to test positive.
2025-04
BioSpace
CorVista Health to Present New Data on Non-Invasive Point of Care Test for Pulmonary Capillary Wedge Pressure Elevation Using Machine Learning at ACC.25
CorVista Health announced an upcoming poster presentation of new data on its non-invasive point-of-care test for pulmonary capillary wedge pressure (PCWP) elevation at the American College of Cardiology's Annual Scientific Session (ACC.25). This test is a key indicator of heart failure with preserved ejection fraction (HFpEF) and uses machine learning.
2025-03
Diagnostic and Interventional Cardiology
CorVista Health Publishes Real-World Case Series Exploring Non-Invasive Test for Diagnosing Pulmonary Hypertension
CorVista Health published a new case series in the Journal of the American College of Cardiology (JACC), showcasing real-world clinical applications of the CorVista System, a non-invasive, point-of-care diagnostic test for pulmonary hypertension (PH). The publication highlights how the FDA-cleared system can enable earlier detection of PH.
2025-09

Frequently Asked Questions

CorVista Health offers the CorVista System, an AI-powered point-of-care imaging and analysis solution designed to rapidly assess cardiac function and detect coronary artery disease without radiation or contrast agents. It integrates into clinical workflows by providing real-time results at the point of care, aiming to streamline diagnostics and reduce the need for downstream testing.
CorVista Health emphasizes the clinical validation of its AI algorithms through ongoing studies and publications. The CorVista System has received FDA 510(k) clearance, demonstrating its compliance with regulatory standards for safety and effectiveness.
While specific pricing details are not publicly disclosed, CorVista Health's business model likely involves a combination of capital equipment acquisition for the CorVista System and potential per-use or subscription fees for the AI analysis and ongoing support. This approach would offer flexibility for various healthcare settings, from large hospitals to smaller clinics.
CorVista Health provides comprehensive support, including initial training for healthcare professionals on the use of the CorVista System and ongoing technical support to ensure optimal performance. This commitment helps users maximize the benefits of the AI platform and maintain proficiency.
CorVista Health aims for seamless integration with existing EHR systems to facilitate data flow and improve clinical decision-making. The company adheres to stringent data security and privacy protocols, complying with HIPAA and other relevant regulations to protect sensitive patient information.
CorVista Health is a privately held company focused on transforming cardiac care with its innovative AI-powered solutions. While specific financial details are not public, their continued development and FDA clearance suggest a commitment to long-term growth and market presence.

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