B-Secur has announced that it has received US Food and Drug Administration (FDA) 510(K) clearance for its HeartKey software library.
B-Secur’s HeartKey is a suite of EKG/ECG algorithms that combine user identification, health and wellness to generate accurate data encrypted through the user’s unique heartbeat, which can be implemented across devices in home or healthcare environments.
The FDA-cleared HeartKey algorithms can be integrated in semiconductors for a range of devices in the consumer wellness, health monitoring and medical technology sectors, B-Secur said, and provides potential for device manufacturers and healthcare service providers to generate advanced medical-grade wellness and health data from any device and platform.
Andrew Mitchell, consultant cardiologist at Jersey General Hospital and honorary consultant cardiologist at John Radcliffe Hospital, Oxford, UK, said: “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.”
“The inspiration around EKG/ECG and HeartKey is being able to take biometrics to the next level, enabling the development of trusted biosensing technology,” Alan Foreman, CEO at B-Secur commented. “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.”
“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,” Adrian Condon, CTO at B-Secur added. “This clearance should significantly aid our partners and customers increase the speed to market for their technology.”
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.