CorVista� System
CorVista Health, Inc.The CorVista System is a non-invasive medical device combining hardware and software to analyze physiological signals from patients with cardiovascular symptoms. Using machine learning, it provides healthcare providers with a likelihood of significant coronary artery disease to aid diagnosis, integrating clinical judgment and patient history. This helps clinicians identify patients who may need further evaluation or treatment.
Intended Use
The CorVista System analyzes sensor-acquired physiological signals of patients presenting with cardiovascular symptoms to indicate the likelihood of significant coronary artery disease as an aid in diagnosis.
Technology
The CorVista System consists of hardware and software components that acquire, transmit, store, and analyze synchronized physiological signals (VCG and PPG) using a machine learning detection algorithm to output a likelihood of significant coronary artery disease.
Performance
Performance was evaluated in a prospective multi-center clinical study on 1,816 symptomatic patients. The device showed 88% sensitivity and 51% specificity in indicating significant coronary artery disease, comparable to coronary computed tomography angiography (CCTA). Additionally, extensive non-clinical safety and software validation testing confirm device performance and repeatability.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/1/2023
7 days - 2
FDA Approval
9/8/2023
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