CorVista System with PH Add-On
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
The CorVista System with PH Add-On offers a non-invasive, rapid, point-of-care solution for diagnosing coronary artery disease and pulmonary hypertension, and shows promise for heart failure assessment. It can be particularly valuable for early detection, triaging patients for more invasive procedures, and reducing diagnostic delays, especially in cases where traditional methods like echocardiography are inconclusive or unavailable. Its ability to provide results within minutes can significantly streamline clinical workflows and facilitate timely treatment decisions.
The CorVista System operates as a 'MedTech-as-a-Service' model, utilizing a cloud-based AI/ML algorithm for analysis. Physiological signals are collected by a portable device, sent to secure cloud databases for processing, and a physician diagnostic report is automatically pushed back to the doctor's office. The system is designed as a platform with a modular design, allowing for the integration of additional AI/ML cardiovascular disease detection algorithms or 'Add-ons' over time.
Details
| Category | Cardiology AI, Radiology & Imaging AI |
| Pricing | Contact for pricing |
| Deployment | Cloud-based (data collected at point-of-care, processed in the cloud, results via secure web portal). |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The CorVista System with CAD Add-On received FDA 510(k) clearance in September 2023 for evaluating the presence of significant coronary artery disease. The CorVista System with Pulmonary Hypertension (PH) Add-On Module received FDA clearance in April 2024 for indicating the likelihood of elevated mean arterial pulmonary pressure (mPAP), an indicator of pulmonary hypertension. The PH Add-On also received Breakthrough Device Designation in 2022. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Internal Medicine, Pulmonology |
What the Web Says
The CorVista System with PH Add-On is a non-invasive, machine-learned, point-of-care diagnostic tool cleared by the FDA to aid in the early detection of pulmonary hypertension (PH) and coronary artery disease (CAD). It uses AI-based algorithms to analyze cardiac and hemodynamic signals, providing results within minutes without the need for radiation, contrast agents, injections, fasting, or exercise. Physicians and medical professionals generally view the system positively due to its potential to shorten diagnostic pathways and improve patient outcomes, especially in underserved areas.
Overall: PositiveStrengths
- Non-invasive and rapid, providing results within minutes at the point of care.
- Aids in earlier diagnosis of pulmonary hypertension and coronary artery disease, potentially improving patient outcomes.
- Utilizes machine learning and AI for precise and reliable diagnostic insights.
- Can be used in low-resource and rural settings, increasing access to advanced cardiovascular diagnostics.
- Demonstrated high sensitivity (82%) and specificity (92%) for detecting elevated mean pulmonary arterial pressure (mPAP).
- Reduces the need for multiple specialist visits and invasive procedures like right heart catheterization.
Limitations
- No specific negative reviews or opinions from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra were found in the search results.
- As a relatively new technology, long-term real-world effectiveness and integration into broader healthcare systems are still being established.
- The anticipated PCWP Add-On algorithm is currently under FDA review and not commercially available.
- While a Category III CPT code has been granted, it is a temporary code for emerging technologies, and a clear reimbursement pathway is still developing.
Based on reviews from: Financial Post, Clinical Lab Products, accessdata.fda.gov, Pulmonary Hypertension News, Diagnostic and Interventional Cardiology, Business Wire, MedicaEx.com, YouTube (The Planetary Health First Mars Next podcast), Medical Technology Enterprise Consortium (MTEC), PMC (PubMed Central), BioWorld
Last updated: 2026-07-17
Ratings & Reviews
No reviews yet. Be the first to review this tool!
Rate CorVista System with PH Add-On
Press & Coverage
Videos
Product demos, reviews, and walkthroughs for CorVista System with PH Add-On.
No videos found. Search YouTube directly
Frequently Asked Questions
Compare CorVista System with PH Add-On
VS
VS
VS
VS
