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