Eko Murmur Analysis Software (EMAS)

by Eko Devices  · Based in United States → — Your partner in precise, proactive heart and lung care with AI-powered detection.
Cardiology Internal Medicine Pediatrics

Regulatory Status Disclosed

Overview

Eko Murmur Analysis Software (EMAS) is a cloud-based, FDA-cleared AI tool designed to assist clinicians in the early detection and differentiation of heart murmurs. Integrated with Eko’s digital stethoscopes (such as CORE 500™, DUO™, and CORE™), EMAS analyzes heart sound (phonocardiogram) and optional electrocardiogram (ECG) data. The software uses advanced signal processing and machine learning algorithms to automatically detect the presence, timing, and character of murmurs, including innocent and structural heart murmurs, in both adult and pediatric patients.

The Eko platform enhances the traditional physical exam by providing digitally amplified audio, active noise cancellation, and visual waveforms of heart sounds and ECG tracings via a mobile app. This technology offers clinical decision support, helping healthcare professionals to diagnose with greater confidence and streamline their workflow. EMAS is part of Eko’s broader SENSORA® Cardiac Early Detection Platform, which also includes FDA-cleared algorithms for detecting atrial fibrillation (AFib) and low ejection fraction (Low EF).

The Eko App, available on iOS and Android, is central to the system, enabling users to record, play back, annotate, and securely store exam recordings. It also facilitates the generation and sharing of PDF reports, which can be uploaded to compatible Electronic Health Record (EHR) systems. Eko’s solutions are designed for a wide range of healthcare settings, supporting individual providers, clinics, and health systems, and are compatible with telehealth solutions for remote care.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • FDA-cleared AI for murmur detection
  • Analyzes heart sound (PCG) and optional ECG data
  • Differentiates innocent and structural heart murmurs
  • Provides clinical decision support
  • Integrates with Eko digital stethoscopes (CORE 500, DUO, CORE)
  • Mobile app for recording, playback, annotation, and saving
  • Wireless Bluetooth connectivity to mobile devices
  • PDF report generation and sharing (EHR compatible)
  • Telehealth compatible for live streaming (with subscription)
  • Secure storage of patient recordings

Use Cases

  • Early detection of heart and lung disease
  • Screening for valvular heart disease
  • Enhancing clinical expertise and diagnostic confidence
  • Remote patient monitoring and telehealth consultations
  • Medical education and patient engagement
  • Identifying low ejection fraction and atrial fibrillation (with broader Eko platform)

What Physicians Need to Know

ECG/EKG Analysis Capability
Eko Murmur Analysis Software (EMAS) analyzes heart sounds, phonocardiograms, and ECG signals (when available) captured by Eko's smart stethoscopes. Eko's AI, including EMAS, detects atrial fibrillation (AFib) and sinus rhythm from the ECG signal and calculates heart rate. AFib detection is intended for adults only.
Echocardiography AI Features
While EMAS itself is not an echocardiography AI tool, it provides decision support that may lead to recommendations for echocardiography or specialist referral if a murmur is detected. Eko's Low Ejection Fraction (Low EF) AI, part of the SENSORAu2122 platform, can detect low ejection fraction, a key indicator of heart failure, and was trained using ECGs and echocardiogram pairs.
Arrhythmia Detection Accuracy
Eko's AI (EFAST/SENSORA) detects Atrial Fibrillation (AFib) with reported sensitivities of 99% and 95%, and specificities of 97% and 94% when analyzing 1-lead ECG tracings from Eko DUO stethoscopes. The software also detects sinus rhythm but does not identify other arrhythmias.
Heart Failure Risk Prediction
Eko has an FDA-cleared algorithm for detecting low ejection fraction (Low EF), a sign of heart failure, which can identify at-risk patients during routine checkups. Clinical studies have shown it correctly identifies low ejection fraction with approximately 85% accuracy (84.8% sensitivity and 69.5% specificity for LVEF u226440% in one study). Eko's AI has also been shown to predict Major Adverse Cardiac Events (MACE), including heart attacks, heart failure, hospitalization, and all-cause mortality.
Cardiac Monitoring Integration
Eko's smart stethoscopes capture and send heart sounds and ECG signals to the cloud in real-time. Recorded data can be securely stored, enabling longitudinal tracking and sharing with colleagues. The platform integrates with Electronic Health Records (EHRs) for seamless documentation and supports telehealth solutions for live streaming of sound and ECG data.
AHA/ACC Guideline Alignment
The software is FDA-cleared and clinically validated, intended to provide decision support to clinicians in evaluating heart sounds and ECGs. It is not a sole means of diagnosis, emphasizing the clinician's role in conjunction with their evaluation and clinical judgment.
Real-Time Alert Capability
Eko's AI (EFAST) processes heart sound and ECG data in real-time, flagging crucial heart disease indicators such as structural murmurs, AFib, and low ejection fraction within approximately 15 seconds, providing immediate insights during the physical exam.
Physician Tip

Eko Murmur Analysis Software (EMAS) and its integrated AI capabilities serve as powerful decision support tools, augmenting rather than replacing clinical judgment. Physicians should leverage EMAS to differentiate between innocent and structural murmurs, guiding appropriate referrals for further diagnostics like echocardiography. Utilize the real-time ECG analysis for prompt detection of AFib and sinus rhythm in adults. The Low EF AI offers a critical advantage for early identification of heart failure risk during routine physical exams, enabling timely intervention. Seamless integration with EHRs facilitates efficient documentation and longitudinal patient monitoring, while telehealth compatibility supports remote consultations. Remember that AI interpretations are assistive and require review by a trained professional in conjunction with the patient's full clinical picture.

Eko's platform is designed for robust integration, offering seamless connectivity with Electronic Health Records (EHRs) for streamlined workflows, including single sign-on, real-time data transmission (audio, ECG, vitals), and direct pushing of AI analysis results (e.g., via PDF or anonymous URL). The cloud-based nature of the software ensures secure storage and sharing of recorded exams. Furthermore, Eko Connect enables unparalleled sound and ECG live streaming for telehealth solutions, integrating with existing telemedicine carts and video platforms. The system is HIPAA compliant and SOC2 certified, ensuring data security.

Details

Category Cardiology AI
Pricing Free for basic ai analysis with the eko app; paid subscriptions required for full features (eko+) and live streaming telehealth capabilities.
  • Basic AI analysis for murmur detection: Free with Eko App; Eko+ membership: Unlocks full app features including AFib detection (with CORE 500™) and murmur detection, recording, saving, and sharing reports; Telehealth subscription: Required for live streaming heart sounds and ECG readings
DeploymentCloud-based service, accessed via mobile application.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Eko Murmur Analysis Software (EMAS) received FDA 510(k) clearance (K213794) on June 29, 2022. It is cleared for detecting and identifying heart murmurs in adult and pediatric patients, and for differentiating innocent and structural murmurs associated with valvular heart disease.

Integrations
EHR Not specified
Specialties Cardiology, Internal Medicine, Pediatrics

What the Web Says

Eko Murmur Analysis Software (EMAS) is an FDA-cleared, cloud-based machine learning algorithm that assists healthcare professionals in detecting and characterizing heart murmurs in both adult and pediatric patients. It analyzes heart sounds, phonocardiograms, and, when available, ECG signals captured by Eko's smart stethoscopes. The software is intended as a decision-support tool for clinicians, not a sole diagnostic means, and has shown significantly improved performance in identifying valvular heart disease compared to traditional auscultation.

Overall: Positive

Strengths

  • Improved accuracy in detecting structural heart murmurs and valvular heart disease compared to traditional stethoscopes.
  • Ability to record and visualize heart sounds, which can be beneficial for education, training, and patient communication.
  • Enhanced sound quality, amplification, and noise cancellation, particularly useful in noisy environments or for clinicians with hearing impairments.
  • Can differentiate between innocent and structural heart murmurs, and identify murmur timing.
  • Integration with digital stethoscopes allows for a more objective and consistent screening process.
  • Potential to improve early detection of heart conditions, leading to better patient outcomes and treatment paths.

Limitations

  • AI features, including murmur and AFib detection, may not be available or cleared for use in all countries (e.g., UK).
  • Some users have reported difficulties with app setup and customer support responsiveness.
  • The device can be cumbersome in certain fast-paced environments like the ED, and some users prefer detaching the chest piece.
  • Concerns about the device potentially picking up clinically insignificant murmurs or making pulmonary auscultation worse for some users.
  • Requires stable network connectivity for full functionality, which can be an issue in rural areas.
  • Some reports of durability issues with the hardware (earpiece malfunction) and shipping delays.

Based on reviews from: PR Newswire, Design News, Patient Care Online, Eko Health, accessdata.fda.gov, PubMed, MD+DI, ClinicalTrials.gov, Fierce Biotech, MedGrade, Physicians Practice, REVIEWS.io, Reddit, Apple App Store, YouTube, Health Innovation North East North Cumbria (HI NENC)

Last updated: 2026-07-19

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Press & Coverage

Eko Health
FDA Clears Eko's Heart Disease Detection AI for Adults and Pediatrics
Eko announced that the FDA has cleared its Eko Murmur Analysis Software (EMAS) for detecting and characterizing murmurs in adults and pediatric patients, making it the first smart stethoscope to differentiate between innocent and structural heart murmurs.
2022-07
Patient Care Online
FDA Clears Heart Murmur Detection AI Software for Eko Digital Stethoscope
The FDA granted clearance to Eko for its EMAS, a cloud-based machine learning algorithm that enables the Eko smart stethoscope to identify and differentiate heart murmurs indicative of valvular heart disease in both adult and pediatric patients.
2022-07
Medical Device Network
Eko Secures FDA Clearance for Heart Disease Detection Software
Eko received FDA clearance for its EMAS, a cloud-based machine learning algorithm that helps healthcare professionals identify valvular heart disease by analyzing heart sounds, phonocardiograms, and ECG signals.
2022-07
MD+DI
Eko Continues to Reimagine the Stethoscope with AI
Eko's EMAS, now FDA-cleared, allows physicians to use their smart stethoscopes with greater confidence to detect signs of cardiovascular disease like valvular heart disease in adults and pediatric patients.
2022-07
Design News
Cloud-Based Algorithms Are Transforming the Stethoscope
Eko's smart stethoscope platform, already FDA cleared for atrial fibrillation, now includes EMAS to detect and characterize murmurs in adults and pediatric patients, differentiating between innocent and valvular heart disease.
2022-07
Medtech Insight
FDA Clears Eko's Smart Stethoscope To Detect Heart Murmurs
Eko's Murmur Analysis Software (EMAS) is the first and only electronic stethoscope software cleared by the FDA to identify and differentiate sounds indicative of valvular heart disease from innocent heart murmurs.
2022-07
ClinicalTrials.gov
Real-World Evaluation of Eko Murmur Analysis Software in a Point of Care Setting
This study aims to evaluate the impact of Eko AI plus EMAS on a clinician's referral decision in a real-world primary care setting, following its FDA 510(k) clearance in June 2022.
2024-09
Clinical and Experimental Pediatrics
Artificial intelligence in pediatric healthcare: current applications, potential, and implementation considerations
Eko Murmur Analysis Software (EMAS) is highlighted as an FDA 510(k) cleared audio signal AI (digital stethoscope analyzed with ML algorithm) for detecting and classifying heart murmurs in pediatric healthcare.
2025-06

Videos

Product demos, reviews, and walkthroughs for Eko Murmur Analysis Software (EMAS).

View all on YouTube

Frequently Asked Questions

EMAS works with Eko's digital stethoscopes and the Eko App or SENSORA platform, automatically analyzing heart sounds during routine exams or spot checks. It provides real-time decision support by identifying potential murmurs, their timing, and character, aiding clinicians in early detection and referral decisions.
EMAS is FDA-cleared for use in both adult and pediatric patients as a decision support tool. Eko Health maintains HIPAA-compliant policies, procedures, and technical safeguards, including 256-bit AES encryption and Business Associate Agreements (BAAs), to protect patient data.
The main alternative is traditional auscultation with an analog stethoscope; however, Eko's AI-enabled stethoscopes have demonstrated significantly higher sensitivity in detecting structural heart murmurs compared to conventional methods. While echocardiography remains the diagnostic gold standard, EMAS serves as an effective screening tool to guide further evaluation and specialist referrals.
Eko offers membership plans like Eko+ for individual providers, which unlocks AI features and can cost around $2.00 per day. For health systems, the enterprise-level SENSORA platform requires direct contact for pricing, and the Centers for Medicare & Medicaid Services (CMS) has established a national payment rate for its AI-assisted cardiac exam, making it reimbursable for hospitals.
EMAS is a decision support tool and not intended as a sole diagnostic method; clinical judgment is always required. Its accuracy may be affected by factors such as patient obesity or loud pulmonary sounds, and it requires a stable network connection and the Eko App for full functionality.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18

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