Eko Low Ejection Fraction Tool (ELEFT)
Overview
The Eko Low Ejection Fraction Tool (ELEFT) is an innovative AI-powered algorithm developed by Eko Health in collaboration with Mayo Clinic. It is designed to aid clinicians in the early identification of individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%, a key indicator of heart failure.
ELEFT integrates seamlessly with FDA-cleared Eko Digital Stethoscopes, such as the CORE 500™, to analyze both electrocardiogram (ECG) and heart sound (PCG) recordings during a routine physical examination. The software uses advanced signal processing and machine learning algorithms to provide a likelihood of low EF within approximately 15 seconds.
This tool is intended to assist healthcare providers in assessing LVEF ≤ 40% and is not a diagnostic tool on its own, but rather a screening tool to prompt further referral or diagnostic follow-up. By embedding rapid and accessible low ejection fraction detection into a familiar stethoscope exam, ELEFT aims to disrupt the status quo of delayed heart failure diagnoses, which often occur due to the inaccessibility or cost of traditional methods like echocardiography in primary care settings.
ELEFT is a component of Eko’s SENSORA™ Cardiac Early Detection Platform, which also includes FDA-cleared algorithms for detecting AFib and structural heart murmurs.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered low ejection fraction detection
- Integrates with FDA-cleared Eko digital stethoscopes
- Analyzes ECG and heart sound recordings
- Provides results in approximately 15 seconds
- Part of the SENSORAu2122 Cardiac Early Detection Platform
- Cloud-based data processing and storage
- Aids in early identification of heart failure risk
- Non-invasive screening tool
Use Cases
- Early detection of heart failure with reduced ejection fraction (HFrEF)
- Screening for low LVEF in primary care settings
- Aiding clinicians in identifying at-risk patients during routine physical exams
- Supporting timely referrals for further diagnostic follow-up
- Enhancing cardiac assessment in telemedicine and remote monitoring (with Eko stethoscopes)
What Physicians Need to Know
ELEFT serves as a valuable screening tool, particularly in primary care and resource-limited settings, to identify patients at risk for low ejection fraction and potential heart failure earlier. It is crucial to remember that ELEFT is not a standalone diagnostic tool; a positive result necessitates further diagnostic evaluation, such as echocardiography, to confirm the diagnosis and guide treatment. Integrate ELEFT findings with a comprehensive clinical assessment, including patient history and symptoms, for optimal patient management. Early identification can facilitate timely specialist referrals and initiation of guideline-directed therapies, potentially preventing hospitalizations and adverse cardiac events.
ELEFT is integrated into Eko's SENSORAu2122 Cardiac Early Detection Platform, which also features other FDA-cleared algorithms for detecting atrial fibrillation and structural heart murmurs. The system relies on data input from Eko's digital stethoscopes and leverages a cloud-based API for data processing and result display across various devices.
Details
| Category | Cardiology AI, Clinical Decision Support & Reference |
| Pricing |
Contact for pricing
|
| Deployment | Cloud-based software integrated with Eko digital stethoscopes. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated Eko Low Ejection Fraction Tool (ELEFT) received FDA 510(k) clearance (K233409) on March 28, 2024. It is classified as Cardiovascular Machine Learning-Based Notification Software, intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Family Medicine, Internal Medicine |
What the Web Says
The Eko Low Ejection Fraction Tool (ELEFT) is an AI-powered software designed to assist clinicians in identifying individuals with a Left Ventricular Ejection Fraction (LVEF) of less than or equal to 40%, a key indicator of heart failure. It analyzes ECG and heart sounds collected via Eko stethoscopes, providing a rapid screening tool during routine physical exams. ELEFT aims to enable earlier detection of heart failure, particularly in primary care settings where traditional diagnostic tools like echocardiography may be less accessible.
Overall: PositiveStrengths
- Rapid detection of low ejection fraction in approximately 15 seconds.
- Aids in early identification of heart failure, potentially preventing hospitalizations and adverse events.
- Utilizes a familiar tool (stethoscope) for screening, making it accessible in various clinical settings, including underserved areas.
- Developed in collaboration with Mayo Clinic and validated through clinical studies.
- FDA-cleared and integrated into Eko's Sensora Cardiac Early Detection Platform, which also detects AFib and structural heart murmurs.
- Demonstrated effectiveness in identifying pregnancy-related cardiomyopathy.
Limitations
- Not intended as a sole means of diagnosis and should not replace an echocardiogram when indicated.
- Requires recordings collected by healthcare professionals or operators with at least 5 years of experience in clinical data collection.
- Performance data, while strong, shows a sensitivity of around 74.7-77.5% and specificity of 77.5-78.3% for LVEF <= 40%.
- The software itself is an API only, without a user interface, and requires access to a separate software program for output display.
- The algorithm was validated on a proprietary database.
Based on reviews from: Eko Health, Inc. (accessdata.fda.gov), MobiHealthNews, BioWorld, Eko Health, PR Newswire, Forbes, MedTech Dive, 24x7 Magazine, Fierce Healthcare, Journal of the American College of Cardiology (JACC) Advances, European Heart Journal u2014 Digital Health, The Lancet Digital Health
Last updated: 2026-07-21
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Normal to severe Low Ejection fraction Echo l EF 15-20% #echo #heartattack #shorts
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