Eko Foundation Analysis Software with Transformers (EFAST)

by Eko Health  · Based in United States → — Smarter cardiac care in seconds.
Cardiology Family Medicine Internal Medicine

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 analyzes ECG and heart sound signals to detect the presence of atrial fibrillation and normal sinus rhythm. It also takes ECG as input to identify individuals with low left ventricular ejection fraction (LVEF).
Echocardiography AI Features
While EFAST primarily focuses on heart sound and ECG analysis, Eko Health has developed algorithms that analyze heart sounds recorded with a digital stethoscope for identifying elevated pulmonary artery systolic pressures, a key indicator of pulmonary hypertension, which is typically diagnosed via echocardiography.
Cardiac CT/MRI Analysis
EFAST does not currently offer Cardiac CT/MRI analysis features.
Arrhythmia Detection Accuracy
EFAST detects atrial fibrillation (AFib) with a reported sensitivity of 92% and specificity of 99%. For AFib detection in adults, the sensitivity is 94.7% and specificity is 94.1%.
Heart Failure Risk Prediction
Eko has an FDA-cleared AI algorithm that captures cases of low cardiac ejection fraction (LVEF ≤ 40%), a key indicator of developing heart failure. This algorithm uses ECG and heart sounds as input for patients at risk for heart failure.
Coronary Artery Assessment
EFAST does not currently offer specific features for coronary artery assessment.
Cardiac Monitoring Integration
EFAST integrates seamlessly with Eko's digital stethoscopes, providing real-time AI analysis alongside enhanced audio, waveform visualization, and guided exam workflows. It delivers AI analysis through the Eko App and Eko+ during the exam.
AHA/ACC Guideline Alignment
Eko's AI-powered algorithms are clinically validated and aim to support earlier detection of cardiovascular diseases. The Eko Low Ejection Fraction Tool (ELEFT) is intended to aid clinicians in identifying individuals with LVEF less than or equal to 40%, a key indicator for heart failure.
Real-Time Alert Capability
EFAST processes heart sound and ECG data in real-time, flagging crucial heart disease indicators like structural murmurs, AFib, and low ejection fraction in seconds. It provides instant feedback and detailed analysis during exams.
Physician Tip

EFAST is intended to support healthcare professionals in evaluating patients' heart sounds and ECGs, calculating heart rate, and detecting murmurs associated with Structural Heart Disease and atrial fibrillation. It is not intended to be used as a sole means of diagnosis, and the interpretations offered by the software are designed to support, not replace, clinical judgment. The murmur detection is for both pediatric and adult patients, while AFib detection is for adults (>18 years). The software integrates into current workflows, providing real-time AI analysis through the Eko App and Eko+ without additional steps or separate portals.

EFAST integrates seamlessly with Eko's digital stethoscopes, including the CORE 500™ Digital Stethoscope and 3M™ Littmann® CORE Digital Stethoscope, within the Eko App and Eko+ software experience. It provides real-time AI analysis, enhanced audio, waveform visualization, and guided exams.

Details

Category Cardiology AI
Pricing Subscription-based, contact for details
DeploymentCloud-based Software as a Medical Device (SaMD)
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Cardiology, Family Medicine, Internal Medicine

What the Web Says

Eko Foundation Analysis Software with Transformers (EFAST) is designed to assist healthcare professionals in evaluating heart sounds and ECG data to detect murmurs, arrhythmias, and low ejection fraction. It is often paired with Eko's digital stethoscopes, such as the CORE 500, to provide real-time AI-powered analysis and improve the detection of cardiac conditions. Many healthcare professionals find it a valuable tool for enhancing diagnostic capabilities and patient education.

Overall: Mixed

Strengths

  • Improved detection of cardiac conditions like murmurs, AFib, and low ejection fraction.
  • Real-time AI-powered analysis of heart sounds and ECG.
  • Enhanced sound quality, amplification, and noise cancellation, especially in loud environments.
  • Ability to record, save, and share patient data for review, consultation, and educational purposes.
  • Integration with EMRs and billing systems for seamless documentation.
  • Useful for patient education by allowing them to hear their own body sounds.

Limitations

  • Potential for reduced specificity, which could lead to false positives and unnecessary referrals.
  • Concerns about data harvesting and privacy due to the requirement of linking professional email or NPI number and inability to delete payment methods.
  • Some users find the device heavy around the neck.
  • Bluetooth connectivity can be unreliable or have a delay.
  • EKG feature may not work well on hairy chests.
  • Durability issues reported by some users, with electronic components failing after a short period.

Based on reviews from: kpi.ua, ekohealth.com, innolitics.com, thehealthtechsignal.com, cardiovascularbusiness.com, iatrox.com, reddit.com, aideviceindex.com, emergenresearch.com, tenereteam.com, trustpilot.com, reviews.io, youtube.com

Last updated: 2026-10-29

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Press & Coverage

ekohealth.com
Eko Foundation Analysis Software with Transformers (EFAST) User Manual, LBL600 V2.
The Eko Foundation Analysis Software with Transformers (EFAST) User Manual provides details on the software, including its atrial fibrillation detection performance and FDA submission data. The document also references published research related to cardiovascular disease detection using AI-enabled stethoscopes.
unknown
emergenresearch.com
FDA cleared Eko's EFAST algorithm for cardiovascular AI
On September 25, 2025, the FDA cleared Eko's EFAST algorithm for cardiovascular AI, adding a new detection capability to the SENSORA platform that will be available to existing customers in a future software release. This clearance builds on a platform already used by over 650,000 devices sold globally.
2025-09
edn.com
Eko Health Achieves FDA Clearance for EFAST Algorithm, First Cardiac “Foundation Model”
Eko Health received FDA clearance for its Eko Foundation Analysis Software with Transformers (EFAST) algorithm, marking the first cardiac “foundation model” for clinical use. This AI is integrated into the Sensora platform to help clinicians detect signs of potential cardiac diseases.
2026-05
bullquill.com
Eko CORE 300 AI stethoscope goes on sale in US for $199
The FDA database entry for "Eko Foundation Analysis Software with Transformers (EFAST)" was decided on August 12, 2025, preceding the clearance of the CORE 300 hardware. The EFAST software, under a separate earlier clearance (K251494), performs murmur analysis on recordings from the new device.
2026-10
techtarget.com
How AI can help target cardiac issues
Eko Health's EFAST foundation model, trained on over 4 million heart sounds and ECG recordings, received FDA clearance in September 2025. The tool is used at Wayne General Hospital for patients showing signs of heart disease, such as shortness of breath or chest pain.
2026-04
cardiovascularbusiness.com
The latest FDA-cleared AI models in cardiology
Eko Foundation Analysis Software with Transformers (EFAST) from Eko Health is among the latest FDA-cleared AI models in cardiology, covering the evaluation of heart sounds and ECG to calculate heart rate, detect murmurs, and determine timing. This software contributes to the growing number of cardiology-focused AI algorithms available.
2026-03
youtube.com
FDA 510(k) K251494: Eko Foundation Analysis Software with Transformers (EFAST)
This video unpacks the FDA 510(k) summary for Eko Health's EFAST software, highlighting its transformer-based AI for digital stethoscopes. EFAST is a cloud-based Software as a Medical Device (SaMD) that analyzes 15-second heart sound and ECG recordings via an API.
2026-10
hardianhealth.com
Eko Foundation Analysis Software with Transformers (EFAST) K251494
The Eko Foundation Analysis Software with Transformers (EFAST) is intended to support healthcare professionals in evaluating heart sounds and ECGs, calculating heart rate, detecting murmurs associated with Structural Heart Disease, and identifying atrial fibrillation. The software is intended for use by or under the supervision of a healthcare professional and not as a sole means of diagnosis.
unknown

Videos

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

View all on YouTube

Frequently Asked Questions

EFAST integrates seamlessly with Eko's digital stethoscopes and the Eko+ software experience. It provides real-time AI analysis alongside enhanced audio, waveform visualization, and guided exams directly within the Eko App during the patient encounter, requiring no additional steps or separate portals.
EFAST is designed to detect structural heart murmurs and atrial fibrillation (AFib). For structural murmurs, it boasts 93% sensitivity and 91% specificity, aiming to reduce alerts for innocent murmurs. For AFib detection, EFAST shows 92% sensitivity and 99% specificity.
EFAST is FDA-cleared for use in detecting structural heart murmurs and atrial fibrillation. Eko Health is also MDSAP and ISO 13485:2016 certified, demonstrating adherence to quality management system standards for medical devices.
While EFAST is intended for use in both pediatric and adult patients for murmur detection, its atrial fibrillation detection is specifically for adults over 18 years. The FDA summary also noted that specificity for pediatric patients dropped to 76.0% for murmur classification, potentially due to confusion with innocent murmurs.
While direct AI alternatives specifically comparable to EFAST's transformer-based analysis for cardiac auscultation are not explicitly detailed as competitors, general EHR and practice management software alternatives to Eko Health include Epic, Carepatron, and ModMed. EFAST differentiates itself with its FDA-cleared AI for real-time murmur and AFib detection integrated with digital stethoscopes.
EFAST is accessible through an Eko+ membership, which unlocks the full features and AI capabilities of the Eko App. An Eko+ membership costs $12.99 per month or $119.99 per year. The CORE 500 digital stethoscope, which integrates with EFAST, costs $389 and includes 14 days of Eko+ membership.

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Suggest an Edit → | Report an issue | 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…
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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