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Friday February 5th, 2021

A Breakthrough for Heart Health Around the World

Ben Carter, CCO, provides insight on the importance of monitoring heart health and how HeartKey®’s FDA cleared algorithms play a key role in supporting this.

With cardiovascular disease (CVD) now the number one cause of death globally, we have taken a hugely significant step forward by securing U.S. Food and Drug Administration (FDA) 510(K) clearance for our HeartKey® technology. Manufacturers of health and medical wearables and devices can now benefit from our medical-grade ECG/EKG technology for in-depth and accurate heart health monitoring.

Today an estimated 17.9 million people die from cardiovascular disease each year according to the World Health Organisation, representing 31% of all global deaths. 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.


Addressing Heart Health is Vital
A key way we can achieve this is by placing a much greater level of control in the hands of consumers and clinicians when it comes to the heart. As part of the critical eco-system transforming the consumer wellness sector, securing FDA clearance for HeartKey® is a major breakthrough.

Our software uses an individual’s heartbeat pattern (EKG/ECG) to both securely identify users and provide health and wellness insights. Now, wearable technology brands can integrate this powerful software into their products from watches and fitness bands through to T-shirts.


“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.”

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


The real time implementation enables the flexible deployment of HeartKey® into any customer architecture with no constraints, giving people the power to monitor their own health.


Remote Monitoring with HeartKey®’s FDA Cleared Algorithms
At this extremely exciting time, myself and the team at B-Secur are working closely with many of the world’s leading biosensing manufacturers in the consumer wellness industry. Digital transformation has for some time been a key priority for all healthcare service providers.

With social-distancing, for now at least, the new world order, remote monitoring of heart health could prove to be life saving for some patients and at the very least time saving for cardiology care teams. We continue to watch as hospitals around the world buckle under the pressures of coronavirus.  In our view, technology is the lynchpin to enabling the healthcare sector to adapt to a changing world.

Rapid moves towards remote monitoring and assessment were ushered in during the pandemic but future ‘smart-hospitals’ were already planning to incorporate IoT connected technology to help doctors assess, diagnose and treat patients remotely.  This removes the need for some non-emergency patients to physically attend the appointment.

While Covid-19 may have accelerated the march towards telehealth, HeartKey® has been seven years in testing. FDA clearance demonstrates the high efficacy, performance and accuracy of the software. FDA clearance has been granted for the following HeartKey® ECG/EKG algorithms: Signal Conditioning, Heart Rate and Arrhythmia Analysis (which includes Atrial Fibrillation, Bradycardia and Tachycardia) algorithms for use across devices in consumer and healthcare environments.


HeartKey® takes ECG/EKG recording far and beyond the hospital environment and simply put, this is a game changer. A game changer that we believe is the key to transforming heart health around the world today and in the future and from our headquarters in Belfast, UK, we are proud to be playing our part.

Ben Carter, CCO, B-Secur


Read the full press release