Eko Murmur Analysis Software (EMAS)
Eko Devices, Inc.The Eko Murmur Analysis Software (EMAS) is a cloud-based AI-driven tool that analyzes heart sound and ECG data to detect and classify heart murmurs, distinguishing between innocent and structural murmurs. It supports clinicians by offering decision support in evaluating heart sounds, enhancing the diagnostic process for pediatric and adult patients without replacing clinical judgment.
Intended Use
The Eko Murmur Analysis Software is intended to provide decision support to clinicians in their evaluation of patients' heart sounds. It analyzes heart sounds and phonocardiograms (and ECG signals, when available). It automatically detects murmurs that may be present and their timing and character, including S1, S2, innocent heart murmurs, structural heart murmurs, and absence of a heart murmur. It is not intended as a sole means of diagnosis and is for use in pediatric and adult patients.
Technology
EMAS is a cloud-based software service that uses signal processing and machine learning algorithms to analyze heart sound and ECG data uploaded via API. It detects signal quality, heart sound timing (S1, S2), murmur presence and classification (no murmur, innocent murmur, structural murmur), and murmur timing during the cardiac cycle. The output is delivered as a JSON file to requesting applications.
Performance
The algorithms were validated retrospectively on a proprietary dataset of 2,380 unique heart sound recordings from 615 subjects aged 0-95 years, collected with Eko digital stethoscopes. Expert cardiologists annotated recordings for signal quality, murmur presence, and timing. Performance showed 85.6% sensitivity and 84.4% specificity for murmur classification and high accuracy for S1 and S2 detection. No adverse events occurred, and testing shows substantially equivalent safety and effectiveness to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/6/2021
6 months - 2
FDA Approval
6/29/2022
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