KardiaAI
AliveCor, Inc.KardiaAI is a software library by AliveCor that analyzes ambulatory ECG rhythms to identify heart conditions such as atrial fibrillation, bradycardia, and tachycardia. It supports integration into other ECG devices and helps clinicians by providing automated ECG noise filtering, heart rate measurement, and rhythm classification to inform diagnosis and monitoring.
Intended Use
KardiaAI is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects. The device supports analyzing data recorded in compatible formats from any ambulatory ECG devices such as event recorders, or other similar devices. The library is intended to be integrated into other device software. The library is not intended for use in life supporting, or sustaining systems, or ECG monitors, or cardiac alarm, or OTC use only devices. It provides ECG noise filtering, heart rate measurement, detection of noisy ECGs, and rhythm analysis for detecting normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia (when prescribed or used under care of a physician).
Technology
KardiaAI is a software library implementing ECG processing and analysis algorithms. It offers an Application Programming Interface (API) to integrate with ambulatory ECG devices, enabling ECG noise filtering, noisy ECG detection, heart rate measurement from ECGs, and classification of heart rhythms such as normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia.
Performance
Non-clinical testing was conducted using ANSI/AAMI EC57:2012 standard ECG databases and proprietary databases, confirming that KardiaAI's algorithms meet performance acceptance criteria comparable to predicate devices. Testing validated the safety and effectiveness of its bradycardia and tachycardia detection, as well as signal processing for multi-lead ambulatory ECG input.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/9/2018
8 months - 2
FDA Approval
3/11/2019
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