B-Secur (Belfast, Northern Ireland) announced that it has received FDA 510(k) clearance for its HeartKey software library to detect heart arrhythmias.
HeartKey’s FDA-cleared algorithms can support 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, according to the company. The FDA clearance covers HeartKey’s signal conditioning, heart rate and arrhythmia analysis EKG/ECG algorithms. The arrhythmia analysis algorithm includes atrial fibrillation, bradycardia and tachycardia.
HeartKey algorithms can be integrated in semiconductors for a broad range of devices in the medical technology, health monitoring and consumer wellness sectors, enabling rapid integration of medical-grade EKG/ECG software with those devices. It also provides the potential for technology device manufacturers and healthcare service providers to generate advanced medical-grade wellness and health data from any device and platform, according to the company. HeartKey can run embedded on a device, on the application layer and via the cloud.
“The inspiration around EKG/ECG and HeartKey is being able to take biometrics to the next level, enabling the development of trusted biosensing technology,” B-Secur CEO Alan Foreman said in a news release. “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,” added company CTO Adrian Condon. “This clearance should significantly aid our partners and customers increase the speed to market for their technology.”