CorVista System with PH Add-On
Analytics for Life, Inc.The CorVista System with PH Add-On is a non-invasive AI-based medical device that analyzes sensor-acquired cardiac electrical and hemodynamic signals to indicate the likelihood of elevated pulmonary arterial pressure, aiding clinicians in diagnosing pulmonary hypertension. It provides results through a user-friendly digital interface and supports healthcare providers by combining the AI output with clinical judgment.
Intended Use
The CorVista System analyzes sensor-acquired physiological signals of patients with cardiovascular symptoms to provide a binary output indicating the likelihood of elevated mean pulmonary arterial pressure (mPAP), an indicator of pulmonary hypertension, aiding diagnosis when used with clinical judgment.
Technology
The system includes hardware components acquiring seven-channel lead ECG signals (VCG) and photoplethysmography (PPG) data, processed by proprietary machine learning algorithms to calculate features and output a likelihood score. It integrates modular Add-On Modules for disease-specific analysis and reports results via tablet and web applications.
Performance
Validation included a prospective, multicenter clinical study with 386 symptomatic subjects, comparing device output to invasive catheterization (reference standard) and echocardiogram adjudication. The device demonstrated 82% sensitivity, 92% specificity, 99% NPV, and an AUC-ROC of 0.95 for detecting elevated mPAP. Repeatability and reproducibility were confirmed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/15/2023
4 months - 2
FDA Approval
4/5/2024
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