B-Secur ECG biometrics achieve FDA Regulatory Clearance
B-Secur announced on Thursday it has received clearance from the U.S. Food and Drug Administration (FDA) 510(K) for the ECG biometrics of its HeartKey software library.
The ECG (or EKG) biometric algorithms that received the clearance are Signal Conditioning, Heart Rate, and Arrhythmia Analysis.
They can now be integrated into semiconductors in a variety of applications, including consumer wellness, health biometrics monitoring, and medical technology.
This will not only enable rapid integration of medical-grade ECG software within those devices but also enable device manufacturers and healthcare providers to extract medical-grade wellness and health data from any device or platform.
“It is excellent and very timely to hear that B-Secur has received FDA clearance for its HeartKey library,” commented Dr. Andrew Mitchell, consultant cardiologist at Jersey General Hospital. “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.”
According to Mitchell, the increasing availability of wearables and IoT devices provides patients and their doctors with additional tools to detect these rhythms early.
B-Secur’s HeartKey technology uses the ECG signal, which can be detected at multiple points across the body, as a biometric to enable the prevention of cardiovascular disease (CVD).
“The inspiration around EKG/ECG and HeartKey is being able to take biometrics to the next level, enabling the development of trusted biosensing technology,” explained B-Secur CEO Alan Foreman. “With heart disease being the world’s single biggest killer, we are perfectly positioned to help save lives.”
B-Secur recently partnered with LifeQ to improve the accuracy of heart-rate biometrics and monitoring wearables further.