A Belfast (NI) biometrics startup, B-Secur, on Thursday announced FDA clearance of its ECG/EKG software library that analyzes individual heartbeats and heart rhythms, which can be implemented across a wide range of health and wellness monitoring devices.
B-Secur received FDA clearance for the following algorithms part of HeartKey ECG/EKG: Signal Conditioning, Heart Rate, and Arrhythmia Analysis, which includes Atrial Fibrillation, Bradycardia and Tachycardia.
According to their release, the algorithms can be integrated into semiconductors for a broad range of devices, enabling rapid integration of medical-grade ECG/EKG software. It also can run embedded on devices, on the application layer, and via the cloud into systems. As a turnkey solution, it can speed the development of new devices or upgrade older types. By upgrading the monitoring capabilities of health and wellness devices, it can extend clinical-grade monitoring out of the clinic or hospital in less obtrusive ways, which is extremely useful for diagnosing transient cardiac conditions such as atrial fibrillation.
Not yet cleared are HeartKey algorithms for heart rate variability (HRV), energy expenditure, and physiological stress. There is also a UserID feature that uses an individual’s ECG/EKG to personalize and protect that person’s physiological data.
B-Secur has raised £11.5 million in multiple venture and one Series A round since its founding in 2002 and in its current iteration in 2014 (Crunchbase).