HeartKey� Rhythm
B-Secur LimitedHeartKey Rhythm is a software platform designed to analyze ECG data from various ambulatory monitoring devices such as Holters and ECG patches. Using a combination of machine learning and signal processing, the software detects heartbeats, assesses rhythm, and identifies arrhythmias to assist healthcare professionals in diagnosing cardiac conditions. It integrates through an API into other ECG management or monitoring systems and supports non-urgent clinical decision making.
Intended Use
HeartKey Rhythm is intended for use by qualified healthcare professionals for analysing ECG data from adults, specifically from single ECG leads recorded by Holters, Extended Holters, ECG Patches, Event Recorders, or similar devices for arrhythmia diagnostics.
Technology
HeartKey Rhythm operates as a software library accessed via a REST API, integrating machine learning algorithms with rule-based calculations to process ambulatory ECG signals. It performs ECG signal conditioning, signal quality assessment, beat detection, ventricular ectopic beat detection, and rhythm analysis. It is designed to be embedded into ECG management or remote monitoring systems, running on cloud, server, or PC platforms.
Performance
Nonclinical performance testing was performed following relevant consensus standards and guidance documents, verifying the device met design and software requirements. Testing included sensitivity, specificity, and positive predictive value evaluation on a large independent dataset of over 1200 ECGs, representing diverse demographics. Software verification, validation, and cybersecurity testing were completed successfully with no residual anomalies, demonstrating the device’s safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/22/2023
8 months - 2
FDA Approval
8/16/2024
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