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Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity. The interpretations of heart sounds and ECG offered by the software are meant only to assist healthcare providers in assessing Left Ventricular Ejection Fraction ≤ 40% , who may use the result in conjunction with their own evaluation and clinical judgment. It is not a diagnosis or for monitoring of patients diagnosed with heart failure. This software is for use on adults (18 years and older).

Eko Low Ejection Fraction Tool (ELEFT) is an algorithm that is intended to aid clinicians to identify individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds from patients at risk for heart failure. The software uses signal processing as well as machine learning algorithms, to analyze the electrocardiogram (ECG) and heart sound/phonocardiogram (PCG) recording signals generated by FDA-cleared Eko Stethoscopes and saved as .WAV file recordings in the Eko Cloud. ELEFT is a machine learning based notification software which employs machine learning techniques to suggest the likelihood of LVEF < 40% for further referral or diagnostic follow-up. It is intended as the basis for further testing and is not intended to provide diagnostic quality output. As an integral part of a physical assessment, clinician's interpretations of this data can help identify previously undiagnosed left ventricular dysfunction in a patient. The ELEFT consists of the following algorithm components: · Eko Low Ejection Fraction Tool API · Waveform Analysis:

The CORE 500 Digital Stethoscope is intended to be used by clinicians or lay users to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician or by lay users). A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.

CORE 500 Digital Stethoscope (CORE 500) is an electronic stethoscope with integrated electrodes for electrocardiogram (ECG). The device consists of a chestpiece, detachable earpiece (Eko Earpiece) and a mobile application (Eko App) and is intended as a digital auscultation tool on patients requiring physical assessment by the clinicians or lay users. CORE 500 provides the ability to amplify, filter, and transfer body sounds with the chestpiece diaphragm, and three lead ECG through electrodes integrated around the chestpiece. The device can be used in a professional healthcare facility and for home use. CORE 500 features three auscultation modes for a better auscultation experience by filtering acoustic data and enhancing the primary frequency range of particular body sounds: Cardiac Mode for heart sounds, Pulmonary Mode for lung sounds, and Wide Band Mode for general auscultation. CORE 500 also detects and computes the heart rate in real time based on the phonocardiogram (PCG) data.