CorVista System with PH Add-On

by CorVista Health  · Based in Canada → — The future of cardiovascular diagnostics
Cardiology Internal Medicine Pulmonology
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Regulatory Status Disclosed

Overview

The CorVista System with PH Add-On, developed by Analytics for Life, is an FDA-cleared, non-invasive cardiovascular diagnostics platform. It utilizes proprietary machine-learned algorithms to analyze cardiac and hemodynamic signals, providing rapid, point-of-care insights into a patient’s cardiovascular health. The system is designed to aid in the diagnosis of significant coronary artery disease (CAD) and pulmonary hypertension (PH) without requiring radiation, contrast agents, injections, fasting, or exercise. Its modular design allows for the integration of disease-specific add-ons, expanding its diagnostic capabilities. The CorVista System delivers actionable diagnostic insights within minutes, accessible via a secure web portal, aiming to improve early detection and patient management in various care settings, including underserved and rural areas.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Non-invasive cardiovascular diagnostics
  • Point-of-care testing
  • Machine-learned algorithms for analysis
  • Analyzes cardiac and hemodynamic signals
  • No radiation, contrast agents, injections, fasting, or exercise required
  • Rapid results available within minutes
  • Secure web portal for physician access to analysis
  • Modular design with disease-specific add-ons (CAD, PH)
  • Aids in diagnosis of Coronary Artery Disease (CAD)
  • Aids in diagnosis of Pulmonary Hypertension (PH)

Use Cases

  • Aid in the diagnosis of Coronary Artery Disease (CAD)
  • Aid in the diagnosis of Pulmonary Hypertension (PH)
  • Early detection and triage of patients with cardiovascular symptoms
  • Extending advanced cardiology diagnostic services to underserved and rural areas
  • Reducing the need for more invasive diagnostic procedures
  • Potential for early detection of heart failure (investigational)

What Physicians Need to Know

ECG/EKG Analysis Capability
The CorVista System analyzes cardiac electrical signals acquired in orthogonal axes via vectorcardiography (VCG). It also uses photoplethysmography (PPG) for hemodynamic signals. The system works similarly to an EKG. The machine-learned algorithm for detecting PH was constructed using 217 features extracted from OVG and PPG signals, with the OVG conduction family contributing most significantly by capturing characteristics of the myocardial conduction pathway, including its variability. The system collects electrical and blood-flow signals during a 3.5-minute resting session. The system processes these signals using AI-based algorithms to produce a binary (yes-or-no) result indicating the likelihood of elevated PCWP.
Heart Failure Risk Prediction
The CorVista System with the Pulmonary Capillary Wedge Pressure (PCWP) Add-On estimates the likelihood of elevated PCWP, a key indicator of heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF). Elevated PCWP reflects the pressure inside the left side of the heart. The system aims to support earlier diagnosis of heart failure, particularly HFpEF, which is often underdiagnosed. The system provides a non-invasive assessment of PCWP, potentially helping patients avoid unnecessary invasive testing and enabling faster, more confident care decisions. The CorVista System supports assessment across conditions that account for up to 75% of people with symptomatic cardiovascular disease.
Coronary Artery Assessment
The CorVista System is FDA-cleared to help detect coronary artery disease (CAD). It received FDA clearance for CAD in September 2023. The system uses machine learning to support the accurate diagnosis of CAD. The diagnostic performance for CAD was demonstrated to be 82% sensitivity and 92% specificity, with a negative predictive value (NPV) of >99% and a 0.95 AUC-ROC. The system can identify significant CAD with 88% sensitivity, comparable to the rule-out performance of coronary computed tomography angiography.
Cardiac Monitoring Integration
The CorVista System is a point-of-care digital health platform that analyzes sensor-acquired physiological signals. The CorVista System Capture device noninvasively collects electrical and hemodynamic signals during a 3.5-minute resting acquisition. The CorVista Base system allows for integration with indication-specific “Add-Ons” which perform data analysis using a machine-learned detection algorithm to indicate the likelihood of specific diseases at the point of care.
AHA/ACC Guideline Alignment
The CorVista System's performance validation for the PH add-on has been described in relation to the definition of PH as an mPAP ≥25 mmHg and mPAP ≥21 mmHg, which aligns with recent changes in the definition of PH. The system's diagnostic accuracy was consistent across PH subtypes, sex, age, BMI, and key comorbidities. The CorVista System's PH indication received FDA Breakthrough Device Designation in 2022. The system's ability to detect PH has been compared to transthoracic echocardiography (TTE), with TTE having limitations in visualizing tricuspid regurgitant velocity (TRV) in a significant percentage of cases. The CorVista System aims to address the limitations of existing diagnostics for PH.
Real-Time Alert Capability
The CorVista System provides diagnostic results within minutes. The CorVista Analysis is available in a secure web portal within minutes of the test to aid physicians in rapidly diagnosing and treating patients with suspected cardiovascular disease. The system is designed to deliver actionable results at the point of care.
Physician Tip

The CorVista System with PH Add-On is a non-invasive, point-of-care tool that can aid in the early detection of pulmonary hypertension (PH), coronary artery disease (CAD), and elevated pulmonary capillary wedge pressure (PCWP), a key indicator of heart failure. It analyzes physiological signals collected during a brief, 3.5-minute resting test, providing a binary output indicating the likelihood of these conditions. This can be particularly useful for patients presenting with cardiovascular symptoms like chest pain, dyspnea, or fatigue, especially when traditional diagnostic methods like echocardiography may be inconclusive or invasive procedures like right heart catheterization are being considered. The system's high negative predictive value for PH and CAD can help rule out these conditions, potentially reducing the need for further invasive testing and accelerating the diagnostic pathway. However, it's crucial to remember that the CorVista System is an aid in diagnosis and its results should always be interpreted in conjunction with clinical judgment, the patient's signs, symptoms, and clinical history. The system aims to improve access to high-quality cardiovascular diagnostics, particularly in underserved settings.

The CorVista System has a modular design, allowing for integration with disease-specific "Add-On Modules" that perform data analysis using machine-learned detection algorithms. The PH Add-On integrates into the existing CorVista System, which is also marketed for coronary artery disease (CAD) and elevated PCWP. A Category III CPT code (1104T) will become effective January 1, 2027, to support reporting for the use of the CorVista System in assessing potential CAD, PH, and elevated PCWP using augmentative algorithmic analysis of orthogonal voltage gradient and photoplethysmography signals.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Unknown
DeploymentCloud-based, point-of-care system.
Mobile AppYes, for data output.
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Cardiology, Internal Medicine, Pulmonology

What the Web Says

The CorVista System with PH Add-On is a non-invasive, AI-powered diagnostic tool designed to aid in the early detection of pulmonary hypertension (PH) and other cardiovascular conditions. It analyzes physiological signals collected during a brief resting period to provide healthcare providers with information to interpret alongside their clinical judgment. The system has received FDA clearance for PH, coronary artery disease (CAD), and elevated pulmonary capillary wedge pressure (PCWP), aiming to reduce the need for invasive testing and accelerate diagnosis.

Overall: Positive

Strengths

  • Non-invasive and quick (3.5-minute resting acquisition)
  • Aids in earlier diagnosis of PH, CAD, and elevated PCWP, potentially reducing diagnostic delays
  • Reduces the need for invasive procedures like right heart catheterization
  • Utilizes machine learning and AI for analysis of physiological signals
  • Demonstrated high sensitivity and specificity in clinical validation studies for PH (82% sensitivity, 92% specificity)
  • Potential to improve access to high-quality cardiovascular diagnostics in underserved and low-resource settings

Limitations

  • Information from independent physician reviews, healthcare IT, tech reviewers, Reddit, G2, and Capterra specifically for "CorVista System with PH Add-On" is limited or not publicly available.
  • The system provides a binary output indicating the likelihood of a condition, which needs to be interpreted alongside clinical judgment and patient history.
  • While FDA cleared, it is an aid in diagnosis and not a standalone diagnostic tool.
  • The system is relatively new, with FDA clearances for its various indications occurring between 2023 and 2026, so long-term real-world outcomes and widespread adoption data may still be emerging.

Based on reviews from: mpo-mag.com, medicaldevice-network.com, perfectrhythm.net, mtec-sc.org, medicaldaily.com, clpmag.com, ersnet.org, pulmonaryhypertensionnews.com, fda.gov, rarediseaseadvisor.com, financialpost.com, businesswire.com, druganddeviceworld.com, capterra.com, nih.gov, dicardiology.com

Last updated: 2026-10-28

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Press & Coverage

mpo-mag.com
CorVista System with Pulmonary Hypertension Add-On Cleared by FDA
Analytics for Life Inc. and CorVista Health Inc. received FDA clearance for the CorVista System with Pulmonary Hypertension (PH) Add-On Module, which is the first FDA-cleared, machine-learned point-of-care technology for indicating the likelihood of elevated mean arterial pulmonary pressure (mPAP). The PH Add-On expands clinicians' diagnostic capabilities to more efficiently identify coronary artery disease (CAD) and PH cardiovascular conditions.
2024-05
clpmag.com
Advanced Cardiovascular POC Testing System Gets FDA Clearance
Analytics for Life and CorVista Health announced FDA clearance of the CorVista System with Pulmonary Hypertension (PH) Add-On Module, a machine-learned point-of-care technology for indicating the likelihood of elevated mean arterial pulmonary pressure (mPAP). The CorVista System with PH Add-On was designated as a Breakthrough Device by the FDA in 2022 due to its potential to improve PH diagnosis.
2024-04
globenewswire.com
CorVista Health Announces European Respiratory Journal Publication Detailing Validation of its Non-Invasive Test for Pulmonary Hypertension
CorVista Health announced the publication of data in the European Respiratory Journal (ERJ) Open Research, validating its machine-learned, non-invasive algorithm for aiding in the diagnosis of pulmonary hypertension (PH) using signals collected by the CorVista System. The study demonstrated that the CorVista System can accurately detect elevated mean pulmonary artery pressure (mPAP) with diagnostic performance comparable to or surpassing current standard-of-care modalities.
2025-05
biospace.com
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 at the American College of Cardiology's Annual Scientific Session (ACC.25) on new data regarding its non-invasive point-of-care test for pulmonary capillary wedge pressure (PCWP) elevation, a key indicator of heart failure with preserved ejection fraction (HFpEF), using machine learning. The CorVista System is a point-of-care digital health solution that detects multiple heart conditions in a single, non-invasive test.
2025-03
businesswire.com
CorVista Health Announces New AMA Category III CPT® 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 (CPT®) code for novel augmentative AI algorithmic analysis of potential coronary artery disease (CAD), pulmonary hypertension (PH), and elevated pulmonary capillary wedge pressure (PCWP). This new code, 1104T, will become effective January 1, 2027, and will support reporting for the use of the CorVista System in assessing these conditions.
2026-07
businesswire.com
FDA Clears CorVista® System PCWP Add-On as a Noninvasive Test For Elevated Pulmonary Capillary Wedge Pressure
CorVista Health and Analytics For Life 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 cardiovascular symptoms to indicate the likelihood of elevated PCWP, a key indicator of suspected heart failure.
2026-07
medicaldevice-network.com
CorVista's AI-based pulmonary capillary wedge pressure add-on test represents the third FDA clearance for its cardiopulmonary platform
The FDA has cleared a new add-on test for CorVista Health's cardiopulmonary diagnostic platform to identify patients with elevated pulmonary capillary wedge pressure (PCWP), a key indicator of suspected heart failure. This PCWP test is CorVista's third FDA clearance, following approvals for coronary artery disease (CAD) in September 2023 and pulmonary hypertension (PH) in April 2024.
2026-07
reachmd.com
CorVista System with PH Add-On
The CorVista System with PH Add-On is an FDA 510(k) cleared diagnostic AI system that analyzes hemodynamic measurements to help cardiologists assess cardiac function and pulmonary pressure status. It processes physiologic data to stratify patient risk and guide therapeutic decisions, reducing manual interpretation burden and standardizing hemodynamic assessment.
2026-05

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Frequently Asked Questions

The CorVista System with PH Add-On is a non-invasive, point-of-care cardiac diagnostic system that uses machine-learned algorithms to analyze electrical and hemodynamic signals collected during a 3.5-minute resting acquisition. It indicates the likelihood of elevated mean pulmonary arterial pressure (mPAP), a key indicator of pulmonary hypertension (PH), and also the likelihood of elevated pulmonary capillary wedge pressure (PCWP), which is relevant for diagnosing heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF). The system is intended to aid physicians in diagnosing patients with suspected cardiovascular disease, including coronary artery disease (CAD), PH, and elevated PCWP.
The CorVista System with PH Add-On has received FDA clearance. The PH Add-On specifically received FDA clearance in April 2024, and its pulmonary hypertension indication was designated as a Breakthrough Device by the FDA in 2022. The system also received FDA clearance for coronary artery disease in September 2023, and for elevated PCWP in July 2026.
No, the CorVista System with PH Add-On does not replace invasive procedures like right heart catheterization. Right heart catheterization remains the reference standard for measuring pulmonary capillary wedge pressure. The CorVista System provides a non-invasive assessment to indicate the likelihood of elevated pressures, offering additional information to clinicians to interpret alongside their clinical judgment and the patient's history, and potentially helping to avoid unnecessary invasive testing.
One limitation noted in a performance validation study was the inability to provide a test result in 16% of patients, although this rate is comparable to MRI which can exhibit motion artifacts. The system is designed to be used as an aid in diagnosis, with results interpreted in conjunction with a healthcare provider's clinical judgment, the patient's signs, symptoms, and clinical history, rather than as a standalone diagnostic tool.
While the CorVista System is a non-invasive, point-of-care cardiac diagnostic system utilizing machine learning, other non-invasive diagnostic tools exist for cardiac assessment. However, the CorVista System is noted as the first FDA-cleared, machine-learned point-of-care technology for indicating the likelihood of elevated mean arterial pulmonary pressure. Other AI-based tools, such as Ultromics' EchoGo Heart Failure AI algorithm, also exist for earlier identification of heart failure.
Specific pricing details for the CorVista System with PH Add-On are not publicly available. However, a Category III CPT code, 1104T, will become effective on January 1, 2027, to support reporting for the use of the CorVista System in assessing potential CAD, PH, and elevated PCWP. Economic analyses suggest that adopting the CorVista System can be economically beneficial by reducing the need for more expensive care and preventing delays in treatment.

Compare CorVista System with PH Add-On

VS
CorVista System with PH Add-On vs Rapid Enterprise Platform
Cardiology AI Adjacent · 65/100
CorVista System with PH Add-On is a point-of-care diagnostic tool specifically for coronary artery disease and pulmonary hypertension, utilizing non-invasive machine-learned algorithms. Rapid Enterprise Platform, while also leveraging…
VS
CorVista System with PH Add-On vs EchoNext
Cardiology AI Direct · 85/100
Both CorVista System with PH Add-On and EchoNext are FDA-cleared AI tools focused on cardiovascular diagnostics, specifically including the detection of pulmonary hypertension. CorVista offers a point-of-care, non-invasive…
VS
CorVista System with PH Add-On vs PMcardio
Cardiology AI Adjacent · 75/100
Both CorVista System with PH Add-On and PMcardio are AI-powered point-of-care diagnostic tools for cardiovascular conditions. CorVista offers a non-invasive assessment for coronary artery disease and pulmonary hypertension…
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CorVista System with PH Add-On vs Sleepiz One+
Cardiology AI Adjacent · 65/100
While both tools are FDA-cleared, AI-powered, and address cardiovascular health, their primary applications differ. CorVista System with PH Add-On is a diagnostic platform for specific cardiovascular diseases like…

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-17 | First Added: 2026-04-17
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