The company gets clearance for the Signal Conditioning, Heart Rate, and Arrhythmia Analysis algorithms


FDA grants 510(K) clearance to select algorithms of B-Secur’s HeartKey EKG/ECG algorithms. (Credit: Hermes Manuel Cortés Meza from Pixabay)

Northern Ireland-based B-Secur has secured the US Food and Drug Administration (FDA) 510(K) clearance of its HeartKey software library.

HeartKey is a suite of EKG/ECG algorithms and analytics that are said to generate accurate data encrypted via the user’s heartbeat by combining user identification, health, and wellness.

The 510(K) clearance from the FDA has been given to the Signal Conditioning, Heart Rate, and Arrhythmia Analysis algorithms. The other algorithms of HeartKey include Physiological Stress, User ID, and Energy Expenditure, which are yet to be cleared by the FDA.

Currently, the HeartKey Arrhythmia Analysis algorithm includes atrial fibrillation, bradycardia, and tachycardia.

B-Secur claimed that the FDA-cleared algorithms of HeartKey can help in the detection and management of arrhythmias outside of the conventional hospital settings.

By using larger amounts of data, the algorithms are said to enable clinicians in making more accurate clinical decisions, said the company.

Jersey General Hospital consultant cardiologist Dr Andrew Mitchell said: “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.”

According to B-Secur, the EKG/ECG algorithm suite can be implemented across devices in-home or healthcare environments. They can run embedded on device, on the application layer, and also through the cloud.

Furthermore, technology device manufacturers and healthcare service providers can produce advanced medical-grade wellness and health data irrespective of their devices and platforms, said the company.

B-Secur CEO Alan Foreman said: “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.”