CardioLogs ECG Analysis Platform
Cardiologs TechnologiesThe CardioLogs ECG Analysis Platform is a software tool that helps qualified healthcare professionals analyze ECG data to assess arrhythmias in adults. It supports uploading ECG recordings from various devices, processes them using a proprietary proprietary algorithm to detect heartbeats and rhythm abnormalities, and provides analysis results as an advisory support to clinicians. This cloud-based platform helps improve ECG interpretation efficiency and accuracy.
Intended Use
The CardioLogs ECG Analysis Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in subjects over 18 years of age, supporting data from Holter, event recorders, 12 lead ambulatory ECG devices, and other similar devices.
Technology
The platform consists of a cloud-based application (Platform as a Service) and a client-side web application. It performs ECG signal processing, feature extraction (P waves, QRS complexes, T waves), multi-label classification of abnormalities, and provides an interface for users to review and edit results. It supports manual or automatic ECG data upload via an API and stores data securely.
Performance
Performance testing included verification and validation against design inputs and clinical gold standards, usability testing, and compliance with multiple recognized consensus standards such as AAMI ANSI IEC 62304 and IEC 60601-2-25. Testing showed no anomalies and met all requirements for safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/27/2017
3 months - 2
FDA Approval
6/26/2017
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