Eko Low Ejection Fraction Tool (ELEFT)

by Eko Health  · Based in United States → — Your new partner in precise, proactive heart and lung care. We created a modern replacement for the stethoscope, and paired it with clinically proven AI and health system integrations for earlier disease detection.
Cardiology Family Medicine Internal Medicine

Regulatory Status Disclosed

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

ECG/EKG Analysis Capability
The Eko Low Ejection Fraction Tool (ELEFT) analyzes single-lead electrocardiogram (ECG) and heart sound (phonocardiogram - PCG) data collected via Eko digital stethoscopes. It utilizes machine learning algorithms for this analysis.
Echocardiography AI Features
ELEFT is not an echocardiography AI tool. Instead, it is designed to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40% by analyzing ECG and heart sounds, particularly in settings where echocardiography is not readily available or indicated. Its performance has been evaluated against echocardiographic EF measurements.
Arrhythmia Detection Accuracy
ELEFT's primary function is LVEF detection and it is not intended to detect arrhythmias. However, studies have shown that among patients flagged by the AI for potential low EF but with normal echocardiograms, a significant percentage had conduction or rhythm abnormalities, suggesting an indirect indication of underlying rhythm issues.
Heart Failure Risk Prediction
ELEFT is intended to aid in identifying individuals with LVEF u2264 40%, a key indicator of heart failure. Patients identified with reduced ejection fraction using Eko Health AI were found to be twice as likely to experience major adverse cardiac events (MACE), including heart attacks, heart failure, hospitalization, and all-cause mortality over two years.
Cardiac Monitoring Integration
ELEFT integrates with FDA-cleared Eko digital stethoscopes (e.g., Eko DUO) to collect ECG and heart sound data. This data is saved as .WAV files in the secure Eko Cloud and can be accessed and displayed on connected mobile devices (smartphones, tablets) or PCs.
AHA/ACC Guideline Alignment
The algorithm uses an LVEF threshold of 40%, which aligns with the point at which most patients become eligible for guideline-directed therapy for heart failure. Early detection of left ventricular dysfunction is emphasized as crucial for improving patient outcomes.
Real-Time Alert Capability
The ELEFT algorithm can provide an actionable signal within approximately 15 seconds when paired with Eko's electronic stethoscopes. It delivers machine learning-based notifications indicating the likelihood of LVEF u2264 40%, prompting further referral or diagnostic follow-up.
Physician Tip

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 Unknown
Mobile App1
Data ExportUnknown
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Cleared AI-estimated
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 algorithm integrated into Eko's smart stethoscopes, designed to help clinicians identify patients with a left ventricular ejection fraction (LVEF) of 40% or less, a key indicator of heart failure. Developed in collaboration with the Mayo Clinic, ELEFT analyzes 15 seconds of ECG and heart sound data during a routine physical exam, aiming to enable earlier detection of heart failure, especially in primary care settings where traditional diagnostic tools like echocardiography may be less accessible. The FDA cleared ELEFT in April 2024, and it is intended for use on patients aged 18 and older who are at risk for heart failure.

Overall: Positive

Strengths

  • Enables early detection of low ejection fraction and potential heart failure during routine physical exams.
  • Utilizes a familiar tool (stethoscope), making it accessible in various clinical settings, including remote and underserved areas.
  • Provides rapid results (15 seconds), streamlining the diagnostic process.
  • Developed in collaboration with the Mayo Clinic and has received FDA clearance.
  • Can help prevent hospitalizations and adverse events by facilitating earlier intervention.
  • Potentially reduces the need for expensive and specialized tests in initial screenings.

Limitations

  • Some Reddit users have reported quality and durability issues with Eko stethoscopes, including loose eartips and connector breakage.
  • The device is solely intended to analyze recordings collected by healthcare professionals or other operators with at least 5 years of experience in collecting clinical data.
  • ELEFT is not intended to provide diagnostic quality output or identify arrhythmias.
  • Requires physician or qualified healthcare professional review and interpretation for every analysis prior to clinical use.
  • While it aids in detection, a confirmatory transthoracic echocardiogram is still needed for a definitive diagnosis of heart failure.

Based on reviews from: eMPR.com, NHS Study Demonstrates Eko Smart Stethoscope Can Identify Heart Failur, MobiHealthNews, accessdata.fda.gov, BioSpace, PR Newswire, MassDevice, Eko Health, Forbes, Fierce Biotech, TechTarget, Reddit, The Medical Futurist, tctmd.com

Last updated: 2026-10-21

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Press & Coverage

Medical Dialogues
FDA clears AI tool to detect heart failure with low ejection fraction - Medical Dialogues
The FDA has cleared Eko Low Ejection Fraction Tool (ELEFT), an AI algorithm that helps physicians identify individuals with left ventricular ejection fraction (LVEF) less than or equal to 40% in 15 seconds using an Eko stethoscope. This marks a significant advancement in early heart failure detection during routine physical examinations.
2024-04
eMPR.com
FDA Clears Tool to Aid in Identifying Patients With Low Ejection Fraction - eMPR.com
The FDA has cleared Eko Low Ejection Fraction Tool (ELEFT), an AI-powered algorithm developed with Mayo Clinic, to assist clinicians in identifying patients with low ejection fraction using ECG and heart sound data from an Eko smart stethoscope. The tool integrates into Eko's SENSORA Cardiac Early Detection Platform.
2024-04
MobiHealthNews
Eko Health's AI-enabled cardiac tool receives FDA clearance | MobiHealthNews
Eko Low Ejection Fraction Tool (ELEFT) received FDA clearance in March, enabling providers to detect low ejection fraction in 15 seconds during routine exams with an Eko stethoscope. This AI-enabled tool will be added to Eko's SENSORA Cardiac Early Detection Platform.
2024-04
FDA
K233409 - 510(k) Premarket Notification - FDA
This FDA 510(k) premarket notification details the clearance of the Eko Low Ejection Fraction Tool (ELEFT), an algorithm from Eko Health, Inc. intended to assist clinicians in identifying individuals with LVEF less than or equal to 40%. The document outlines the regulatory information and classification of the device.
2024-03
PR Newswire
Eko Health Announces New Study Demonstrating AI-Assisted Detection of Reduced Ejection Fraction - PR Newswire
Eko Health announced a new study demonstrating the effectiveness of its AI-assisted detection of reduced ejection fraction, highlighting the potential of AI-enhanced digital stethoscope technology for earlier identification of heart failure. The study involved 2,960 adults and showed the platform's promise in complementing traditional diagnostics.
2025-03
PubMed
Automated Detection of Reduced Ejection Fraction Using an ECG-Enabled Digital Stethoscope: A Large Cohort Validation - PubMed
This peer-reviewed study validated a convolutional neural network (CNN) model using single-lead electrocardiogram and phonocardiogram inputs from a digital stethoscope to detect low ejection fractions. The model demonstrated an area under the receiver operating characteristic curve of 0.85 with a sensitivity of 77.5%.
2025-02
Cardiovascular Business
Cardiovascular device approvals continue to lead the FDA's Breakthrough Device Program
Eko Low Ejection Fraction Tool (ELEFT) is highlighted as a cardiovascular device approved under the FDA's Breakthrough Device Program. It is an automated software augmentation for stethoscopes to aid clinicians in identifying LVEF less than or equal to 40% using ECG and heart sounds.
2025-08
MDPI
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting - MDPI
This article discusses machine learning-enabled medical devices authorized by the FDA in 2024, including the Eko Low Ejection Fraction Tool (ELEFT). It provides regulatory characteristics, such as its 510(k) clearance and use of deep learning for low ejection fraction detection from heart sounds.
2025-12

Videos

Product demos, reviews, and walkthroughs for Eko Low Ejection Fraction Tool (ELEFT).

View all on YouTube

Frequently Asked Questions

The Eko Low Ejection Fraction Tool (ELEFT) is an AI-powered algorithm that analyzes ECG and heart sound data, acquired via an Eko digital stethoscope, to identify individuals with a Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. It's intended to aid clinicians in the early detection of heart failure, particularly in patients at risk, by providing a rapid assessment during routine physical examinations.
ELEFT received FDA 510(k) clearance in March 2024, signifying its approval for clinical use as a diagnostic aid to screen for low ejection fraction. Eko Health, the developer, is also MDSAP and ISO 13485:2016 certified.
While echocardiography remains the gold standard for LVEF assessment, ELEFT offers a non-invasive, point-of-care screening tool. Other AI algorithms, such as LVsense, also aim to detect reduced LVEF from standard 12-lead ECGs. ELEFT's advantage lies in its integration with a digital stethoscope, allowing for rapid screening during routine physical exams.
ELEFT is intended as an aid for clinicians and should not replace an echocardiogram when indicated. Its performance has been validated in at-risk populations, and further study is needed regarding its use in otherwise healthy individuals. Additionally, the reproducibility of signal acquisition between different providers requires further investigation.
Specific pricing for ELEFT is not publicly detailed, but Eko states that its advanced stethoscope technology can cost as little as $2.00 a day. ELEFT is integrated into Eko's SENSORA Cardiac Early Detection Platform, which offers various FDA-cleared algorithms. SENSORA analyses performed in eligible outpatient settings may be reimbursable under CPT Category III code 0962T.
In a clinical study, ELEFT demonstrated a sensitivity of 74.7% and a specificity of 77.5% for detecting LVEF less than or equal to 40% in patients at risk for heart failure. Another study showed an area under the receiver operating characteristic curve (AUROC) of 0.85, with a sensitivity of 77.5% and a specificity of 78.3%.
ELEFT is designed to be used with Eko digital stethoscopes during routine physical examinations, allowing for rapid assessment within 15 seconds. While the exact integration details with EHRs are not explicitly stated, Eko's platform aims to streamline assessments and provide early cardiac insights.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-20 | First Added: 2026-04-20

Investors who backed Eko Low Ejection Fraction Tool (ELEFT)

Funded through the company that built this tool.

Tomorrow Capital
VC T2
Mumbai, India
$1M-$5M
Tomorrow Capital is a Mumbai-based early-stage operational VC with a clear focus on tech-enabled healthcare delivery and consumer wellness brands, writing checks…
Care Delivery / Tech-Enabled Services Wellness / Consumer Health
Lightbox Ventures
VC T2
Mumbai, India
$5M-$25M
Lightbox Ventures is a Mumbai-based venture capital firm with a multi-vintage record of backing consumer technology and wellness platforms in India. Check…
Digital Health Wellness / Consumer Health
EDBI
Corporate VC AI T2
Singapore, Singapore
$5M-$25M
EDBI is the strategic investment arm of the Singapore Economic Development Board, headquartered in Singapore with a global mandate and a long…
AI/ML in Healthcare Biotech
Pegasus Capital
PE T3
Dublin, Ireland
$5M-$25M
Pegasus Capital is a Dublin-based corporate finance and private equity advisory firm that executes high-value domestic health sector transactions across Ireland. The…
Care Delivery / Tech-Enabled Services
Sutter Health Ventures
Corporate VC T3
Sacramento, United States
$1M-$5M
Sutter Health Ventures is the strategic venture entity of Sutter Health, a major California-based health system headquartered in Sacramento. The fund backs…
Care Delivery / Tech-Enabled Services Digital Health
ah! Ventures
Angel Network T3
Mumbai, India
<$250k
ah! Ventures is one of India’s earliest organized angel networks and a multi-stage early-stage investor backing founders across consumer, fintech, SaaS, healthcare,…
Digital Health MedTech
Wildwood Ventures
VC T3
Denver, United States
$250k-$1M
Wildwood Ventures, at wildwood.vc with LinkedIn and Crunchbase profiles, is an early-stage venture firm without disclosed stage, sector, or check size in…
AI/ML in Healthcare Digital Health
Ulu Ventures
VC T3
Palo Alto, United States
$1M-$5M
Ulu Ventures is a Bay Area early-stage firm at uluventures.com with a Crunchbase profile and active LinkedIn presence, known for a disciplined…
AI/ML in Healthcare Care Delivery / Tech-Enabled Services
Target Global
VC T3
Berlin, Germany
$1M-$5M
Target Global is a European multi-stage technology investment firm with offices in Berlin, London, and other locations, investing across software, marketplaces, financial…
AI/ML in Healthcare Care Delivery / Tech-Enabled Services
Lifeforce Capital
VC T3
San Francisco, United States
$250k-$1M
Lifeforce Capital presents as an early-stage venture investor with a thesis tilt toward longevity, performance health, and consumer biology, though detailed public…
AI/ML in Healthcare Biotech
Keiretsu Forum Spain
Angel Network T3
Barcelona, Spain
$250k-$1M
Keiretsu Forum Spain is the Spanish chapter of the global Keiretsu Forum angel investment network, comprised of accredited angel investors who collectively…
Biotech Diagnostics
DxAngels
Syndicate T3
San Francisco, United States
$250k-$1M
DxAngels is an angel network or syndicate with a website but no LinkedIn or Crunchbase presence in the source data and no…
AI/ML in Healthcare Biotech
DigiTx Partners
VC T3
San Francisco, United States
$1M-$5M
DigiTx Partners is a healthcare and life sciences venture capital firm with a thesis spanning digital health, healthtech, and adjacent technology-enabled healthcare…
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