Eko Analysis Software

by Eko Devices  · Based in United States → — Your new partner in precise, proactive heart and lung care.
Cardiology Emergency Medicine Internal Medicine
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Freemium with subscription for full features
Regulatory Status Disclosed

Overview

Eko Analysis Software, also known as Eko AI, is FDA-cleared software designed to support physicians in the evaluation of patients’ heart sounds and ECGs. It analyzes simultaneous ECG and heart sounds to detect the presence of atrial fibrillation (AFib), normal sinus rhythm, and suspected murmurs. The software also calculates cardiac time intervals such as heart rate and QRS duration. Integrated with Eko’s digital stethoscopes and mobile application, it provides real-time visualizations and decision support to clinicians, aiding in the early detection of cardiovascular diseases. It is intended as a support tool for the physician and not as a sole means of diagnosis.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • FDA-cleared AI for heart murmur detection
  • FDA-cleared AI for atrial fibrillation (AFib) detection
  • Detection of normal sinus rhythm
  • Calculation of cardiac time intervals (heart rate, QRS duration)
  • Wireless auscultation with Bluetooth-enabled devices
  • Recording, playback, and annotation of heart sounds and ECGs
  • Visualization of phonocardiograms (PCG) and ECG tracings
  • Secure cloud-based storage of recordings within the US
  • Generation and sharing of PDF reports (EHR compatible)
  • Guided 4-point cardiac exams

Use Cases

  • Early detection of cardiovascular diseases (murmurs, AFib, low ejection fraction)
  • Clinical decision support during routine physical exams
  • Telehealth and remote patient monitoring
  • Medical education and training for auscultation skills
  • Streamlining documentation and cardiology referrals
  • Tracking changes in patient cardiac condition over time

What Physicians Need to Know

ECG/EKG Analysis Capability
Eko Analysis Software, in conjunction with Eko digital stethoscopes (e.g., Eko DUO, CORE 500u2122), provides 1-lead or 3-lead ECG tracings. The software analyzes the ECG signal to detect atrial fibrillation (AFib), normal sinus rhythm, sinus tachycardia, and sinus bradycardia. It also calculates cardiac time intervals such as heart rate and QRS duration.
Arrhythmia Detection Accuracy
Eko's FDA-cleared AI can detect AFib with high accuracy, reporting 99% sensitivity and 97% specificity when analyzing 1-lead ECG from the Eko DUO stethoscope, and 95% sensitivity and 94% specificity with EFAST. It also detects sinus tachycardia and sinus bradycardia.
Heart Failure Risk Prediction
Eko's SENSORAu2122 platform includes FDA-cleared AI for detecting low ejection fraction (LVEF u226440%), a significant risk factor for heart failure. Studies have shown its AI can predict major adverse cardiac events (MACE) and all-cause mortality, with patients flagged for low EF being twice as likely to experience MACE.
Cardiac Monitoring Integration
Eko Analysis Software integrates with Eko's digital stethoscopes for real-time auscultation and ECG visualization. It supports telehealth solutions, allowing live-streaming of stethoscope sounds and ECGs, and offers secure cloud storage for recordings, enabling tracking over time and sharing with colleagues. Integration with Electronic Medical Records (EMRs) for seamless documentation is also available.
AHA/ACC Guideline Alignment
Eko's AI algorithms and devices are FDA-cleared and clinically validated, with numerous peer-reviewed publications supporting their accuracy in detecting conditions like AFib, heart murmurs, and low ejection fraction, which are critical components of AHA/ACC guidelines for cardiovascular disease management.
Real-Time Alert Capability
Eko's FDA-cleared AI processes heart sound and ECG data in real-time, flagging crucial heart disease indicators such as structural murmurs, AFib, and low ejection fraction within seconds during patient exams. The Eko App provides immediate notifications of these potential findings.
Physician Tip

Eko Analysis Software, combined with Eko's digital stethoscopes, enhances the physical exam by providing objective data and AI-powered insights for early detection of cardiovascular diseases like AFib, heart murmurs, and low ejection fraction. It's particularly valuable in primary care settings where access to advanced diagnostics may be limited, allowing for quicker identification of at-risk patients and more confident referral decisions. Remember that AI results are intended as decision support and should always be used in conjunction with clinical judgment and patient history. Leverage the recording and sharing features for longitudinal monitoring, consultations, and patient education. Ensure high-quality recordings for optimal AI analysis, especially in noisy environments.

Eko Analysis Software seamlessly integrates with Eko's suite of digital stethoscopes (CORE 500u2122, COREu2122 Digital Attachment, DUOu2122, 3Mu2122 Littmannu00ae CORE Digital Stethoscope). It offers robust telehealth integration through Eko Connect APIs, enabling live-streaming of heart sounds and ECGs with video conferencing solutions. The platform also supports integration with Electronic Medical Records (EMRs) for streamlined documentation and secure cloud storage for patient data, facilitating tracking and sharing across care teams.

Details

Category Cardiology AI, Wearables & Remote Monitoring (RPM)
Pricing Freemium with subscription for full features
  • Basic Eko App features are free; Eko+ membership required for full AI-powered detection capabilities, saving recordings, patient profiles, and PDF reports; Telehealth livestreaming requires a paid subscription
DeploymentCloud-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Eko Analysis Software received FDA clearance K192004 on January 15, 2020. It is cleared to provide support to physicians in the evaluation of heart sounds and ECGs, detecting atrial fibrillation, normal sinus rhythm, and suspected murmurs.
Integrations
EHR Not specified
Specialties Cardiology, Emergency Medicine, Internal Medicine

Ratings & Reviews

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Frequently Asked Questions

Eko Analysis Software, or Eko AI, is an FDA-cleared tool that pairs with digital stethoscopes to assist clinicians in detecting suspected structural murmurs, atrial fibrillation (AFib), and low ejection fraction. It enhances the physical exam by providing real-time visualizations, sound amplification, noise cancellation, and automatic record-keeping, integrating seamlessly into both virtual and in-person patient encounters.
Eko's AI has demonstrated high sensitivity and specificity for detecting AFib and structural murmurs, with studies showing significant improvement in detection rates compared to traditional methods. However, it is intended as a supportive tool, not a sole diagnostic means; it detects the presence of suspected abnormalities but does not classify murmurs as innocent or pathologic, nor does it identify all types of arrhythmias or heart attacks.
Yes, Eko maintains HIPAA-compliant policies, procedures, and technical safeguards for patient and customer data, including NIST-recommended 256-bit AES encryption for data at rest and in transit. All patient data is stored in the cloud within the United States, and Eko is SOC 2 certified, ensuring robust security protocols.
Access to the full features of Eko Analysis Software, including AI-powered detection, typically requires an Eko+ annual membership, with a complimentary trial period included with stethoscope purchases. While detailed pricing is available within the Eko App, the Centers for Medicare & Medicaid Services (CMS) has recognized Eko's SENSORA platform, establishing a reimbursement rate for its Category III CPT code, which can facilitate broader adoption and potential reimbursement.
While the market for AI-powered auscultation tools is evolving, Eko Health is a leading digital health company in this space, offering FDA-cleared AI for heart and lung disease detection. Direct competitors offering similar AI-driven auscultation analysis may exist, but many listed alternatives tend to be broader EHR or practice management solutions that integrate with various medical technologies.
No, Eko AI is designed to support and enhance a physician's clinical expertise, not replace it. The software's interpretations of heart sounds and ECGs are significant only when used in conjunction with physician over-read and professional judgment. It serves as a screening and detection aid, often prompting the need for more complete analyses, such as a cardiologist referral or a 12-lead ECG.

Compare Eko Analysis Software

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