Eko Low Ejection Fraction Tool (ELEFT)
Eko Health, Inc.Eko Low Ejection Fraction Tool (ELEFT) is an AI-based software device that analyzes ECG and heart sound recordings to help clinicians identify patients with reduced left ventricular ejection fraction (LVEF ≤ 40%), a marker of potential heart failure. It is intended for use on adults at risk of heart failure and supports referral decisions for further testing like echocardiography, without replacing diagnostic procedures.
Intended Use
Software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) ≤ 40% from ECG and heart sounds in patients at risk for heart failure, including those with coronary artery disease, diabetes, cardiomyopathy, hypertension, and obesity; for use in adults 18 years or older.
Technology
The device uses machine learning algorithms and signal processing to analyze ECG and phonocardiogram signals collected by FDA-cleared Eko Stethoscopes, processing data via a web-based API with deep convolutional neural networks to classify LVEF ≤ 40%; it outputs likelihood notifications for clinical referral, not diagnostic confirmation.
Performance
Performance validation was conducted on a proprietary database with 3,456 paired ECG and heart sound recordings, validated against gold standard echocardiogram measurements. Sensitivity was 74.7% and specificity 77.5% for detecting LVEF ≤ 40%. Testing included significant demographic variation analysis and software verification per IEC 62304 standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/6/2023
5 months - 2
FDA Approval
3/28/2024
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