HeartKey® Rhythm: A Revolution in Cardiac Monitoring

Introduction 

Executive Summary 

B-Secur is revolutionising cardiac health monitoring with its proprietary HeartKey^® technology, addressing the critical issue of noise in ECG data that impacts remote monitoring systems.  

Our FDA 510(k) cleared HeartKey software processes ECGs with clinical-grade accuracy, enhancing interpretation and improving clinical workflows. HeartKey has been shown to reduce low-quality events requiring review by 40.6% and our filtering techniques have been shown to reduce the amount of data deemed undiagnosable due to noise by 9.7% and improve rhythm classification accuracy by 4.9%. This white paper details our innovative approach, robust R&D efforts, and the transformative impact of HeartKey on healthcare systems. 

Who Is B-Secur? 

B-Secur are at the forefront of the next generation of wellness and healthcare solutions, blending our expertise in engineering with the demands of modern medical technology. We are committed to enhance the quality of data from wearables and medical devices, from smartwatches to patches, improving efficiency and accuracy. Our Professional Services team works directly with engineers, empowering them to make optimised design decisions, while our proprietary ECG algorithms enhance the signal and create clarity for our healthcare staff 

Our Motivation: A Response to a Growing Need  

B-Secur is driven by a critical observation: the rising prevalence of cardiovascular diseases (CVD) worldwide, accounting for 20 million deaths annually¹, up to 90% of which are preventable². Traditional cardiac monitoring methods face significant challenges, including pervasive issues with signal noise, particularly in ambulatory settings. This noise can obscure critical data, leading to delays in care, misdiagnoses, and inefficient resource use. Our flagship technology, HeartKey, is designed to directly address these challenges, offering a robust solution that enhances data clarity and accuracy, ultimately improving patient outcomes. 

Innovative Approach to Cardiac Monitoring 

HeartKey is not just a solution; it’s a revolution in cardiac health monitoring. With over eight years of dedicated research and development, our team initially began by exploring the use of ECG signals for biometric authentication. Focusing on the unique requirements of this technology, including dry electrode utilisation and high accuracy ECG acquisition, lead us to tackling noise reduction head-on. By leveraging expertise from fields such as automotive and semiconductor technologies, we’ve significantly enhanced the fidelity and utility of traditionally challenging ECGs, unlocking their potential for cardiac health monitoring. 

Teamwork at the Core 

Our diverse R&D teams are the backbone of B-Secur. Each team brings specialized expertise, from enhancing the fidelity of biosignals to integrating these advancements seamlessly into consumer and medical devices. This collaborative effort ensures that our products are not only cutting edge but also practical and user-centric. 

 

Understanding ECG Noise: Sources, Implications, and Prevalence 

Sources of Noise in ECG Monitoring 

ECG recordings are critical for diagnosing and monitoring cardiac health but are susceptible to various types of noise that can significantly degrade data quality. These sources of noise fall into two primary categories: corporeal and technical. 

• Corporeal Sources: These are physiological in origin and include baseline wander — typically caused by respiration or patient movement — muscle noise, which arises from electromyographic signals due to muscle contractions, and electrode noise, originating from movement at the electrode-skin interface. 
• Technical Sources: These encompass a range of artificial interferences such as powerline interference, which results from the electrical supply, and noise introduced by other medical equipment. 

Implications and Prevalence of ECG Noise Interference 

ECG noise interference has serious clinical implications. Artifacts resembling arrhythmias can mislead clinicians and automated systems, resulting in inappropriate therapeutic interventions and unnecessary diagnostic procedures, which increase patient distress and healthcare costs³. Additionally, severe noise interference can render significant portions of ECG recordings clinically unactionable, creating additional clinical burdens and inefficiencies⁴. This often necessitates repeat investigations to obtain usable data, delaying therapeutic treatment and potentially leading to poorer patient outcomes. 

The prevalence of noise in cardiac monitoring is a well-recognized issue within the medical community. Studies indicate that over 53% of remote ECG monitoring systems are affected by noise, impacting their clarity and utility⁵. 92% of healthcare professionals have reported significant noise contamination necessitating repeat investigations in ≥10% of ECGs acquired during clinical practice⁶.   

 

Introducing HeartKey Rhythm: A Leap in Cardiac Health Technology  

The Development Journey of HeartKey Rhythm 

Following rigorous research and development, B-Secur launched HeartKey at CES (Consumer Electronics Show) 2019, and shortly after, received FDA 510(k) clearance for the HeartKey health algorithms in early 2020. B-Secur is now proud to introduce HeartKey Rhythm, an FDA 510(k) cleared, groundbreaking advancement in the field of ECG processing and analysis software. HeartKey Rhythm embodies our commitment to innovation, built on a foundation of over 2 million hours of consumer and medical ECG data, translating to more than 8 billion heartbeats analysed. This extensive data has allowed us to refine our algorithms to provide unmatched accuracy and reliability in ECG processing and analysis. 

Regulatory Approval and Quality Assurance 

FDA 510(k) clearance of HeartKey Rhythm (K233755), affirms that it not only meets but exceeds the stringent safety and efficacy requirements of medical device software. This clearance is a testament to the quality-focused approach that has been a cornerstone of our development process from the start.  

Advisory and Supportive Role in Clinical Settings 

HeartKey Rhythm is designed to complement and enhance the clinician’s expertise, not replace it. By delivering high-quality ECG processing and analysis, HeartKey Rhythm supports clinicians in making informed decisions. It provides reliable data that clinicians can use to better understand ECG patterns, patient history, and other diagnostic information, allowing their expertise to truly shine and ensure optimal patient care. 

Designed for Facile Integration and Versatility

HeartKey Rhythm is a cloud-based software library specifically designed to process ECGs in challenging ambulatory environments. It seamlessly integrates within the signal processing chains of various medical devices, including Holter monitors, ECG patches, and Mobile Cardiac Telemetry (MCT) systems. A key advantage of our technology is its deployment as a Docker container; a flexible, standalone package that includes everything needed to run the software, ensuring that no patient data ever leaves your system, offering complete control over data security and privacy. To date, over 100 HeartKey Rhythm licences have been issued, demonstrating its wide acceptance and reliability in the field.  

Features and Clinical Benefits 

HeartKey Rhythm provides a suite of advanced ECG signal processing and analysis algorithms designed to streamline ECG workflow and aid clinical decision-making.  

• Signal Conditioning: HeartKey Rhythm employs adaptive filtering techniques to target and remove common sources of ECG noise interference, such as baseline wander, muscle noise, and powerline interference, and enhance signal clarity. This preprocessing step is crucial for maintaining the fidelity of the ECG signal, particularly in ambulatory settings where movement and external electrical noise can distort readings. 
• Signal Quality Assessment: Before any critical analyses occur, HeartKey Rhythm evaluates the signal quality to identify and flag low-quality signals, allowing only high-quality ECGs to proceed to triage for arrhythmia assessment. By ensuring that only high-quality data is analysed, we minimize the risk of diagnostic errors associated with noise, both by healthcare professionals and downstream interpretation algorithms. Additionally, this allows healthcare professionals to focus on meaningful, actionable data, without the distraction of unactionable data, therefore improving efficiency in the clinical workflow. 
• Beat Analysis: Accurate beat detection is fundamental to all subsequent ECG analysis. HeartKey Rhythm excels in this area, with robust algorithms that ensure precise detection and classification of normal beats and ventricular ectopic (VE) beats. By mastering this essential aspect, we provide a reliable foundation for all downstream algorithms, ensuring the highest accuracy and confidence in our ECG analysis. 
• Heart Rate Detection: HeartKey Rhythm includes advanced heart rate detection algorithms designed to provide precise and reliable heart rate measurements. 
• Rhythm Analysis: The rhythm analysis feature leverages the cleaned signals, along with their accurately identified beat types and locations, to perform a comprehensive evaluation that can detect the most common cardiac rhythms. This analysis aids clinicians in diagnosing a range of cardiac abnormalities, providing a deeper insight into the patient’s cardiac health. 

HeartKey Rhythm Validation  

Comprehensive validation ensures reliability in diverse monitoring scenarios, which is why this was an absolute priority during the development of HeartKey Rhythm. Each aspect of HeartKey Rhythm was independently validated to ensure optimal performance. 

 

Conclusion  

B-Secur’s HeartKey technology emerges as a pivotal innovation in cardiac health monitoring. Our advanced filtering techniques and robust signal processing significantly reduce noise in ECG data, leading to better diagnostic accuracy and streamlined clinical workflows. We remain committed to pushing the boundaries of innovation and ensuring quality in every aspect. 

Why Choose HeartKey Rhythm?  

• Proven Performance: Validated on over 8 billion beats to ensure performance in a variety of challenging environments 

• Regulatory Assurance: With FDA 510(k) clearance, HeartKey meets high standards for safety and efficacy. 

• Versatile Deployment: HeartKey offers flexible deployment as a Docker container, fitting seamlessly into various clinical environments and ensuring that no patient data ever leaves your system, offering complete control over data security and privacy. 

Call to Action 

Embrace the next generation of cardiac health monitoring, offering superior clarity, accuracy, and efficiency. We urge healthcare providers, medical device manufacturers, and technology partners to collaborate with us in this transformative endeavour. By integrating HeartKey into your systems, you can elevate patient care, streamline workflows, and combat the global challenge of cardiovascular diseases. 

 

Citations

¹ https://www.who.int/en/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)

²American Heart Association – CDC Prevention Programs | American Heart Association. Retrieved April 25, 2022, from www.heart.org/en/get-involved/advocate/federal-priorities/cdc-prevention-programs 

³ El-Sherif, N. & Turitto, G. Ambulatory electrocardiographic monitoring between artifacts and misinterpretation, management errors of commission and errors of omission. Ann. Noninvasive Electrocardiol. 20, 282-289 (2015).  

⁴ Karaoğuz, M. R. et al. The quality of ECG data acquisition, and diagnostic performance of a novel adhesive patch for ambulatory cardiac rhythm monitoring in arrhythmia detection. J. Electrocardiol. 54, 28-35 (2019). 

⁵ Survey of >1,600 EPS; Ding EY. Cardiovasc DigitHealth J. 2020. 

⁶ McKenna S, et al. Evaluating the impacts of digital ECG denoising on the interpretive capabilities of healthcare professionals, Eur Heart J Dig Health. 2024; ztae063.