Eko Foundation Analysis Software with Transformers (EFAST)

by Eko Health  · Based in United States → — Smarter cardiac care in seconds.
Cardiology Family Medicine Internal Medicine
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Subscription-based, contact for details
Regulatory Status Disclosed

Overview

Eko Foundation Analysis Software with Transformers (EFAST) is a cloud-based Software as a Medical Device (SaMD) designed to offer clinical decision support to healthcare professionals. It aids in the evaluation of patients’ heart sounds (phonocardiogram, PCG) and electrocardiograms (ECGs). The software utilizes advanced signal processing techniques and deep neural networks to simultaneously analyze recorded heart sounds and ECG data, identifying the presence of murmurs associated with Structural Heart Disease and determining their timing. When ECG data is available, EFAST also accurately detects atrial fibrillation and normal sinus rhythm. Built upon Eko’s proprietary cardiac foundation model, trained on millions of anonymized heart sound and ECG recordings, EFAST delivers robust performance across various cardiac conditions. It seamlessly integrates with Eko’s digital stethoscopes within the Eko+ software experience, providing real-time AI analysis, enhanced audio, waveform visualization, and guided examinations for clearer, more actionable insights at the point of care.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered structural murmur detection (93% sensitivity, 91% specificity)
  • AI-powered atrial fibrillation (AFib) detection (95% sensitivity, 94% specificity)
  • Real-time AI analysis during auscultation
  • Enhanced audio with noise cancellation and amplification
  • Waveform visualization and guided exams
  • Seamless integration with Eko digital stethoscopes (e.g., CORE 500)
  • Cloud-based recording and secure storage of exams
  • EMR integration for streamlined documentation
  • Differentiation of systolic, continuous, and diastolic murmur timing
  • Calculates heart rate and determines murmur timing

Use Cases

  • Early detection of cardiovascular disease in primary care settings
  • Screening for structural heart murmurs during routine physical exams
  • Detecting atrial fibrillation to prevent stroke
  • Providing clinical decision support at the point of care
  • Monitoring patient cardiac health over time through recorded exams
  • Facilitating telemedicine and virtual care consultations

What Physicians Need to Know

ECG/EKG Analysis Capability
EFAST processes ECG data in real-time, detecting atrial fibrillation (AFib) and normal sinus rhythm. It provides clearer rhythm classification, reduces unclassified ECG results, and calculates heart rate, identifying 'Sinus tachycardia' or 'Sinus bradycardia' when ECG is available.
Arrhythmia Detection Accuracy
EFAST detects Atrial Fibrillation (AFib) with 95% sensitivity and 94% specificity during routine exams. It also enhances rhythm classification and minimizes unclassified ECG results.
Heart Failure Risk Prediction
EFAST helps flag crucial heart disease indicators, including structural murmurs, AFib, and low ejection fraction. An FDA-cleared AI algorithm, co-developed by Eko and Mayo Clinic, can detect low ejection fraction (a key indicator of heart failure) with 85% sensitivity and 70% specificity, aiding in earlier identification of at-risk patients.
Cardiac Monitoring Integration
EFAST integrates seamlessly with Eko's digital stethoscopes (Littmann CORE, CORE attachment, CORE 500 series) and the Eko+ software experience. It offers real-time AI analysis alongside enhanced audio, waveform visualization, and guided exams.
AHA/ACC Guideline Alignment
EFAST is FDA-cleared and clinically validated in over 70 publications, focusing on the detection of structural murmurs, AFib, and low ejection fraction, which are critical areas addressed by major cardiovascular guidelines.
Real-Time Alert Capability
EFAST provides real-time AI analysis, flagging crucial heart disease indicators such as structural murmurs, AFib, and low ejection fraction in as little as 15 seconds during the patient exam. It delivers AI analysis directly through the Eko App and Eko+.
Physician Tip

EFAST serves as a powerful clinical decision support tool, enabling more accurate and rapid identification of structural murmurs and atrial fibrillation at the point of care. This can significantly reduce unnecessary referrals for innocent murmurs and facilitate earlier detection of critical conditions like heart failure. It is designed to complement, not replace, a clinician's judgment and is particularly beneficial in primary care and emergency settings for faster, more confident decision-making.

EFAST is designed for seamless integration with Eko's digital stethoscopes (Littmann CORE, CORE attachment, and CORE 500 series) and operates within the Eko App and Eko+ software. It also supports integration with Electronic Medical Records (EMRs) for streamlined documentation. Currently, EFAST is FDA-cleared for use in the U.S. market only.

Details

Category Cardiology AI
Pricing Subscription-based, contact for details
  • Eko+ membership (yearly); Free trial included with stethoscope purchase; Eko's advanced stethoscope technology costs ~$2.00/day
DeploymentCloud-based Software as a Medical Device (SaMD)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

EFAST received FDA clearance K251494 on August 12, 2025. It is the first FDA-cleared foundation model for cardiovascular AI, indicated to detect structural heart murmurs and atrial fibrillation with greater specificity and faster exam times.
Integrations
EHR Not specified
Specialties Cardiology, Family Medicine, Internal Medicine

What the Web Says

Eko Foundation Analysis Software with Transformers (EFAST) is an FDA-cleared, cloud-based AI software designed to assist healthcare professionals in detecting structural heart murmurs and atrial fibrillation (AFib) in real-time during auscultation using Eko digital stethoscopes. It aims to provide immediate, actionable insights at the point of care, reducing unnecessary referrals by focusing on clinically meaningful murmurs. The software has demonstrated high sensitivity and specificity for detecting both structural murmurs and AFib.

Overall: Positive

Strengths

  • Real-time AI analysis during auscultation for immediate insights.
  • High sensitivity (93%) and specificity (91%) for structural murmur detection.
  • High sensitivity (95%) and specificity (94%) for AFib detection.
  • Seamless integration with Eko digital stethoscopes and Eko+ app.
  • Aids in reducing unnecessary follow-ups by focusing on clinically meaningful murmurs.
  • Potential for improved rhythm classification and reduced unclassified ECG results.

Limitations

  • Primarily cloud-based SaMD, which might limit deployment flexibility compared to some competitors.
  • Subscription-based pricing, with an additional yearly membership for Eko+ AI features.
  • The software does not distinguish between different kinds of murmurs and does not identify other arrhythmias beyond AFib.
  • Not intended as a sole means of diagnosis and requires physician over-read.
  • Some users have reported issues with customer support and receiving refunds/replacements.
  • Requires stable network connectivity for optimal use, especially during home visits.

Based on reviews from: AI Verdict (Eko Foundation Analysis Software with Transformers (EFAST) vs Sonix Health), AI Verdict (Eko Foundation Analysis Software with Transformers (EFAST) vs VitalConnect VitalPatch), AI Verdict (Eko Foundation Analysis Software with Transformers (EFAST) vs Zio AT ECG Monitoring System - Medical AI Tools for Physicians), accessdata.fda.gov, Eko Health, AI Verdict (Eko Foundation Analysis Software with Transformers (EFAST) vs EchoGo Core), AI stethoscopes in 2026: Eko CORE 500 review and what UK/US clinicians should know, Eko Health Receives First FDA Clearance for Cardiac Foundation Model, Eko+ - Eko Health, An Evaluation of an Eko Digital Stethoscope, The EKO CORE 500 Digital Stethoscope With ECG And AI: Review - The Medical Futurist, PR Newswire, YouTube

Last updated: 2026-07-18

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Press & Coverage

Eko Health (via MedTech Innovator)
Eko Health Receives First FDA Clearance for Cardiac Foundation Model
Eko Health announced FDA clearance for its EFAST algorithm, the first FDA-cleared cardiac foundation model, designed to detect structural heart murmurs and atrial fibrillation with improved specificity and faster exam times.
2025-09
Eko Health
Meet EFAST: Eko's Most Advanced Cardiac AI Yet
Eko Health introduced EFAST, an AI model that helps clinicians identify structural murmurs more accurately and detect atrial fibrillation with high sensitivity and specificity during routine exams.
2025-09
EDN
AI/ML integration in medical systems - EDN
Eko Health's EFAST algorithm, the first cardiac 'foundation model' for clinical use, has been integrated into the Sensora platform to help clinicians quickly and accurately detect signs of potential cardiac diseases.
2026-05
accessdata.fda.gov
510(k) Premarket Notification - FDA
This FDA premarket notification details the Eko Foundation Analysis Software with Transformers (EFAST) as a cloud-based Software as a Medical Device (SaMD) for clinical decision support in evaluating heart sounds and ECGs.
2025-08
TechTarget
How a rural community hospital deploys AI to detect heart disease | TechTarget
Wayne General Hospital partnered with Eko Health to deploy its EFAST foundation model, which received FDA clearance in September 2025, to detect heart disease in patients exhibiting relevant clinical indicators.
2026-04
Eko Health
How Eko Combines a Stethoscope, ECG & AI Detection - Eko Health
EFAST, Eko's FDA-cleared AI, processes heart sound and ECG data in real-time with digital stethoscopes, detecting structural murmurs and AFib for a clearer picture of cardiac health.
unknown
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances - Innolitics
Eko Health, Inc.'s Eko Foundation Analysis Software with Transformers (EFAST) received 510(k) clearance in August 2025, as part of a review of cardiology AI/ML SaMD clearances for the year.
2026-01
Eko Health Help Center
Regulatory - Eko Help Center
The Eko Help Center lists the FDA Clearance Statement K251494 for the Eko Foundation Analysis Software with Transformers (EFAST) under its regulatory information.
unknown

Videos

Product demos, reviews, and walkthroughs for Eko Foundation Analysis Software with Transformers (EFAST).

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Frequently Asked Questions

EFAST is a cloud-based Software as a Medical Device (SaMD) designed to provide clinical decision support by analyzing heart sounds and electrocardiograms (ECGs). It aids healthcare professionals in evaluating patients' cardiac health by calculating heart rate and detecting structural heart murmurs and atrial fibrillation.
EFAST is indicated for the detection of structural heart murmurs and atrial fibrillation, and it also helps determine murmur timing, including S1 and S2 heart sounds. When used with Eko's digital stethoscopes, it can also flag potential signs of low ejection fraction or a weakened heart pump.
No, EFAST is intended to support healthcare professionals and should not be used as the sole means of diagnosis. The interpretations of heart sounds and ECGs offered by the software are designed to augment, not replace, a physician's clinical judgment.
Yes, EFAST received FDA clearance in September 2025, making it the first FDA-cleared foundation model for cardiovascular AI. This clearance signifies its demonstrated safety and effectiveness for its intended use.
As a cloud-based Software as a Medical Device (SaMD) from Eko Health, EFAST adheres to regulatory standards for medical devices, which include data security and privacy requirements. The AI model was trained using over four million de-identified heart sound and ECG recordings, demonstrating a commitment to patient data protection during its development.
EFAST does not distinguish between different types of murmurs and does not identify arrhythmias other than atrial fibrillation. It is not intended as a standalone diagnostic tool, and its interpretations are significant only when used in conjunction with a physician's clinical over-read.
Specific pricing details for EFAST are not publicly available in the provided information. However, it is integrated into Eko's digital stethoscopes within the Eko+ software experience, which often implies a subscription-based model for accessing its AI features. Healthcare providers typically need to contact Eko Health directly for pricing information.

Compare Eko Foundation Analysis Software with Transformers (EFAST)

VS
Eko Foundation Analysis Software with Transformers (EFAST) vs Sleepiz One+
Cardiology AI Adjacent · 65/100
EFAST is designed for real-time cardiac auscultation and ECG analysis to detect structural murmurs and atrial fibrillation during routine clinical exams. Sleepiz One+ is a contactless remote patient…
VS
Eko Foundation Analysis Software with Transformers (EFAST) vs EchoNext
Cardiology AI Adjacent · 75/100
EFAST and EchoNext are adjacent competitors in the cardiology AI space, both FDA-cleared and focused on early detection of heart conditions. EFAST leverages digital stethoscopes to analyze heart…
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Eko Foundation Analysis Software with Transformers (EFAST) vs Cardiomo
Cardiology AI Adjacent · 65/100
Eko Foundation Analysis Software (EFAST) is designed for real-time cardiac insights during clinical examinations using digital stethoscopes, focusing on structural murmurs and AFib detection. Cardiomo, conversely, provides continuous…
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Eko Foundation Analysis Software with Transformers (EFAST) vs PMcardio
Cardiology AI Adjacent · 65/100
Both tools leverage AI for cardiac diagnostics, but they focus on different data inputs and conditions. EFAST specializes in real-time auscultation analysis for structural murmurs and AFib detection,…

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

Investors who backed Eko Foundation Analysis Software with Transformers (EFAST)

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…
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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…
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