Corvair
AliveCor, Inc.Corvair is an AI-powered software that analyzes resting ECG recordings to detect various heart rhythms, morphological abnormalities, and measure ECG intervals. It supports healthcare professionals by providing an initial automated interpretation of ECGs to assist in cardiac diagnosis, enhancing accuracy and efficiency in clinical settings.
Intended Use
AliveCor’s Corvair ECG analysis system assists healthcare professionals in measuring and interpreting resting diagnostic ECGs for rhythm and morphological information by providing an initial automated interpretation, intended as an adjunct to clinical findings and requiring physician review.
Technology
Corvair is a software medical device that analyzes a 10-second diagnostic-bandwidth ECG using deep neural networks trained on approximately 1 million ECGs. It supports analysis of 4 leads using signal processing and machine learning to provide 35 rhythm and morphology determinations, interfaced via an API library for integration into target devices.
Performance
Corvair underwent extensive nonclinical testing comparing its diagnostic performance (sensitivity, specificity, PPV) against a large dataset and a predicate device (K141963). Interval estimation was validated with standard ECG databases. No clinical testing was conducted. A Predetermined Change Control Plan enables ongoing algorithm improvements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/7/2023
1 year, 2 months - 2
FDA Approval
6/7/2024
Other devices from AliveCor, Inc.
- KardiaAI2019 • 510K
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