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The Eko Analysis Software is intended to provide support to the evaluation of patients ' heart sounds and ECG's. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence of suspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normal sinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRS duration and EMAT. The software does not distinguish between different kinds of murmurs and does not identify other arrhythmias. It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software are only significant when used in conjunction with physician over-read and is for use on adults (> 18 years).

The Eko Analysis Software is a cloud-based software API that allows a user to upload synchronized ECG and heart sound/phonocardiogram (PCG) data for analysis. The software uses several methods to interpret the acquired signals including signal processing and artificial neural networks. The API can be electronically interfaced, and perform analysis with data transferred from multiple mobile or computer based applications. The EAS software is only intended to be used in conjunction with data acquired using two previously-cleared physiological data acquisition devices (Eko DUO (K170874) and Eko CORE (K151319)). The software is designed to be used with companion mobile apps that are used during data acquisition. After analysis, results are returned through an interface to the mobile apps for display. The algorithm consists of the following components: - Rhythm detection algorithm: A neural network model that uses ECG to detect normal sinus rhythm and atrial fibrillation. - Murmur detection algorithm: A neural network model that uses heart sounds to detect the presence of murmurs. - Heart rate analysis algorithm: A signal processing algorithm that uses ECG or heart sounds as appropriate to calculate heart rate. It also provides an alert if the measured heart rate is indicative of Bradycardia or Tachycardia. - QRS duration algorithm: A signal processing algorithm that measures the width of the QRS pulse on a single-channel ECG. - EMAT Interval algorithm: A signal processing algorithm that uses Q peak detection and S1 envelope detection to measure the Q-S1 interval, defined as electromechanical activation time or EMAT.