B-Secur receives FDA Regulatory Clearance

B-Secur Receives FDA Regulatory Clearance For Its HeartKey® EKG/ECG Technology. Expands portfolio across Health, Wellness and User Identification for deployment in consumer and medical technology sectors

Belfast, Northern Ireland, UK, February 4 2021 — B-Secur, a leader in EKG/ECG technology, today announced that it has received U.S. Food and Drug Administration (FDA) 510(K) clearance of its HeartKey® software library^[1]. B-Secur’s HeartKey® is a suite of powerful EKG algorithms that uniquely combine user identification, health and wellness to generate accurate data encrypted through the user’s unique heartbeat, which can now be implemented across devices in home or healthcare environments, with the ability to run embedded on device, on the application layer and even via the cloud.

The FDA-cleared HeartKey® algorithms can be quickly and easily integrated in semiconductors for a broad range of devices in the consumer wellness, health monitoring and medical technology sectors, enabling rapid integration of medical-grade EKG software with those devices. It also provides the potential for all leading technology device manufacturers and healthcare service providers to generate advanced medical-grade wellness and health data from any device and platform.

“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.”
Dr Andrew Mitchell, Consultant Cardiologist, Jersey General Hospital and Honorary Consultant Cardiologist at the John Radcliffe Hospital in Oxford, UK

This significant development from B-Secur comes at an important time for cardiovascular disease (CVD), which is the No. 1 cause of death globally with an estimated 17.9 million people dying from the disease each year, representing 31% of all global deaths[2]. Last year, the COVID-19 pandemic led to additional health 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. Developed and optimised for everyday devices, HeartKey® provides the ultimate flexibility in integration, truly enabling “EKG/ECG Everywhere.”

FDA clearance has been granted for the following EKG/ECG feature algorithms: Signal Conditioning, Heart Rate and Arrhythmia Analysis. The HeartKey® Arrhythmia Analysis algorithm currently includes Atrial Fibrillation, Bradycardia and Tachycardia. Arrhythmias are typically transient, and therefore can be 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, allowing clinicians to make more accurate clinical decisions based on larger amounts of data.

“The inspiration around EKG/ECG and HeartKey® is being able to take biometrics to the next level, enabling the development of trusted biosensing technology. With HeartKey®, EKG/ECG is used to determine who you are and how you are at the same time, and can help protect lives, data, and devices. With heart disease being the world’s single biggest killer, we are perfectly positioned to help save lives.”
Alan Foreman, CEO, B-Secur

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 as well as driving speed to market for end devices.

“HeartKey® has been developed to enable scalability of medical grade EKG/ECG 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.”
Adrian Condon, CTO, B-Secur

[1] Access to U.S. Food and Drug Administration (FDA) HeartKey® clearance details for software library K200884.pdf

[2] World Health Organisation, https://www.who.int/en/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)