B-Secur receives FDA Regulatory Clearance for its advanced HeartKeyÒ technology

Medical-grade ECG/EKG software now available for use across a broad range of medical equipment & clinical devices

Belfast, Northern Ireland, UK, 4 February 2021 — B-Secur, a leader in ECG/EKG technology, today announced it has received U.S. Food and Drug Administration (FDA) 510(K) clearance of its HeartKey® software library1.

This key development in heart health provides the potential for medical technology manufacturers and healthcare service providers to access advanced medical-grade wellness and health data from any device and platform.

B-Secur’s unique portfolio of Wellness and User Identification algorithms combined with its newly FDA cleared Health algorithms, enable rapid integration of medical-grade EKG/ECG software with a broad range of medical equipment and clinical devices in the med-tech sector as well as consumer wellness sector.

This significant development from B-Secur comes at an important time for cardiovascular disease (CVD) which is the number one cause of death globally with an estimated 17.9 million people dying from the disease each year representing 31% of all global deaths2. In the last year, the emergence of COVID-19 has led to additional complications for those with underlying heart conditions. The virus has also caused irreparable cardiac damage and arrhythmias in people with no underlying heart issues, making heart health and remote monitoring a key priority for patients, clinicians and health service providers around the world.

FDA clearance has been granted for the following ECG/EKG feature algorithms: Signal Conditioning, Heart Rate and Arrhythmia Analysis. The HeartKey® Arrhythmia Analysis algorithm currently includes Atrial Fibrillation, Bradycardia, and Tachycardia. As a lot of arrhythmias are typically transient, they are difficult to catch in hospital. With 33 million people experiencing Atrial Fibrillation worldwide, HeartKey®’s FDA cleared algorithms can support in the detection and management of arrhythmias outside of the traditional hospital environment. This allows clinicians to make more accurate clinical decisions based on larger amounts of data.

Dr Andrew Mitchell, Consultant Cardiologist, Jersey General Hospital and Honorary Consultant Cardiologist at the John Radcliffe Hospital in Oxford, UK, welcomed the development commenting: “It is excellent and very timely to hear that B-Secur has received FDA clearance for its HeartKey® library. Heart rhythm conditions affect one in four adults, yet many have no awareness that they have a problem that could lead to stroke or heart failure. With the increasing availability of wearable and IOT devices, FDA cleared solutions like HeartKey® give patients and their doctors additional tools to detect these rhythms early.”

Alan Foreman, CEO, B-Secur commented: “HeartKey® enables secure, advanced medical-grade wellness and health data from any device and platform. This will have a radical impact on the medical tech and healthcare sector. The inspiration around ECG/EKG and HeartKey® is being able to take biometrics to the next level, enabling the development of trusted biosensing technology. With HeartKey®, ECG/EKG is used to determine who you are and how you are at the same time, and can help protect our lives, data, and devices. With heart disease being the world’s single biggest killer, we are perfectly positioned to help save lives.”

B-Secur’s HeartKey® consists of a suite of powerful ECG/EKG algorithms that uniquely combine user identification, health, and wellness to generate accurate data encrypted through the user’s unique heartbeat. Developed and optimised for modern everyday devices, HeartKey® provides the ultimate flexibility in integration, truly enabling “ECG/EKG Everywhere”.

The HeartKey® library has been cleared for implementation across devices in home or healthcare environments, with the ability to run embedded on device, on the application layer and even via the cloud.

FDA clearance of the HeartKey® software library ensures B-Secur customers and partners can have confidence in its world-leading algorithm performance and accuracy. The fully validated, turnkey solution with FDA clearance will ease integration – reducing development time and costs and driving speed to market for end devices.

For medical technology partners and customers of B-Secur, submitting an individual FDA application traditionally requires high levels of algorithm development and testing which can often be challenging to plan and execute. However, those integrating HeartKey®’s ECG/EKG features within their end products save both time and extensive resources.

Adrian Condon, CTO, B-Secur added: “HeartKey® has been developed to enable scalability of medical grade ECG/EKG across IOT devices and the award of FDA clearance is testament to HeartKey®’s performance and the very talented team behind it. This clearance should significantly aid our partners and customers increase the speed to market for their technology.”


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