HeartKey® Rhythm
Overview
HeartKey® Rhythm is a cloud-based software library and suite of advanced ECG algorithms and analytics developed by B-Secur Limited. It is specifically designed to process electrocardiograms (ECGs) in challenging ambulatory environments, such as those from Holter monitors, ECG patches, and Mobile Cardiac Telemetry (MCT) systems. The technology focuses on enhancing signal clarity by employing adaptive filtering techniques to reduce common sources of ECG noise interference, like baseline wander, muscle noise, and powerline interference. This preprocessing step is crucial for maintaining the fidelity of the ECG signal and improving diagnostic accuracy.
HeartKey® Rhythm provides robust algorithms for precise beat detection and classification, advanced heart rate detection, and comprehensive arrhythmia analysis. It aims to streamline ECG workflows and aid clinical decision-making by delivering high-quality ECG data. The software is FDA 510(k) cleared (K233755), affirming its adherence to stringent safety and efficacy requirements for medical device software.
A key advantage of HeartKey® Rhythm is its flexible deployment as a Docker container, which ensures that patient data remains within the user’s system, offering complete control over data security and privacy. It can be integrated seamlessly within the signal processing chains of various medical devices and platforms, including through a Web API.
The tool is intended for use for signal processing and analysis of ambulatory ECGs, for non-active patient monitoring or non-urgent clinical decision making. It is offered to physicians and clinicians on an advisory basis only, in conjunction with their knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information, and is not intended to be the sole means of diagnosis.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Advanced Signal Conditioning for noise reduction
- Accurate Beat Analysis (normal and ventricular ectopic beats)
- Precise Heart Rate Detection
- Heart Rate Variability (HRV) Analytics
- Comprehensive Arrhythmia Analysis (e.g., Atrial Fibrillation, Bradycardia, Tachycardia)
- Stress Analytics
- ECG-based User Identification
- Cloud-based software library
- Docker container deployment for data security
- Seamless integration with medical devices
Use Cases
- Processing ECGs from Holter monitors
- Analyzing data from ECG patches
- Integration with Mobile Cardiac Telemetry (MCT) systems
- Enhancing diagnostic accuracy in ambulatory settings
- Streamlining clinical workflows for ECG interpretation
- Aiding clinical decision-making for cardiac conditions
What Physicians Need to Know
Leverage HeartKeyu00ae Rhythm's advanced signal conditioning to improve the clarity of ECG data, especially from ambulatory settings, reducing noise and enhancing diagnostic confidence. Utilize its rhythm analysis and beat detection capabilities for accurate identification of common cardiac rhythms, including normal beats, ventricular ectopic beats, atrial fibrillation, bradycardia, and tachycardia. The FDA 510(k) clearance provides assurance of clinical-grade accuracy, allowing for more efficient and reliable interpretation of ECGs and streamlined clinical workflows. Focus on the high-quality ECGs identified by the signal quality assessment feature to minimize diagnostic errors and improve workflow efficiency. Consider its integration capabilities with existing cardiac monitoring devices (Holter, patches, MCT) for a unified and enhanced monitoring solution.
HeartKeyu00ae Rhythm is designed as a flexible, cloud-based software library, deployable as a Docker container, on devices, or via a Web API. It seamlessly integrates into the signal processing chains of various medical devices, including Holter monitors, ECG patches, and Mobile Cardiac Telemetry (MCT) systems. It also connects to and enhances existing platforms and wearables, ensuring data security and privacy by allowing patient data to remain within the user's system.
Details
| Category | Cardiology AI, Wearables & Remote Monitoring (RPM) |
| Pricing | Contact for pricing |
| Deployment | Cloud (Docker container); On-device |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated HeartKey® Rhythm received FDA 510(k) clearance (K233755) on August 16, 2024, as a programmable diagnostic computer for signal processing and analysis of ambulatory ECGs. It is intended for non-active patient monitoring or non-urgent clinical decision making and is offered on an advisory basis, not as the sole means of diagnosis. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Emergency Medicine, Internal Medicine |
What the Web Says
HeartKeyu00ae Rhythm, developed by B-Secur, is a software-based electrocardiogram (ECG) technology designed for integration into various devices to provide continuous heart health monitoring. Reviews highlight its potential for early detection of cardiac issues and its non-invasive nature, making it appealing for consumer health applications as well as clinical use. The technology aims to provide medical-grade ECG data through everyday devices.
Overall: PositiveStrengths
- Non-invasive and continuous heart health monitoring
- Potential for early detection of cardiac abnormalities (e.g., AFib)
- Software-based, allowing for broad integration into various devices (wearables, smart home devices)
- Medical-grade ECG data collection
- User-friendly and accessible for consumers
- Reduces the need for specialized hardware
Limitations
- Relatively new technology, limited long-term real-world data from widespread adoption
- Accuracy and reliability in diverse real-world conditions may vary and require further validation
- Integration challenges with existing healthcare IT systems
- Potential for data privacy and security concerns with continuous biometric data collection
- Requires regulatory approvals for medical device classification in different regions
- User compliance and understanding of results may be a factor in effectiveness
Based on reviews from: B-Secur official website, Healthcare IT News, MobiHealthNews, Digital Health Age, Med-Tech Innovation News, Wearable Technologies
Last updated: 2026-07-20
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