FDA Approves Wearable Biometrics Algorithms for Medical Use

The US Food and Drug Administration has granted 510(K) clearance to B-Secur’s HeartKey algorithms. The news will allow technology developers to deploy the company’s EKG and ECG software into their medical and other products.

The certification covers B-Secur’s HeartKey algorithms for Signal Conditioning, Heart Rate, and Arrhythmia Analysis. The software can be embedded in a semiconductor to run at the device level. It can also be baked into an application or delivered through the cloud.

In all three cases, HeartKey will enable the collection of medical-grade EKG and ECG data. The technology is designed primarily for the health monitoring and consumer wellness industries, though it can ultimately be incorporated into any device or platform looking to take advantage of heart rate biometrics. For example, B-Secur’s heart rate monitoring technology can be used for secure biometric authentication in a variety of settings.

B-Secur noted that COVID-19 has led to complications for people with underlying heart conditions, and caused severe cardiac damage in people with otherwise healthy hearts. As a result, the coronavirus has increased the need for quality heart monitoring technology that can track the long-term effects of the disease and lead to better treatments over time. In that regard, remote monitoring is expected to help spot conditions like arrhythmias, which are often transient and are therefore difficult to identify at a hospital or during a scheduled appointment.

“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,” said Jersey General Hospital Consultant Cardiologist Andrew Mitchell. “With the increasing availability of wearable and IoT devices, solutions like HeartKey give patients and doctors additional tools to detect these rhythms early.”

“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,” added B-Secur CEO Alan Foreman.

B-Secur received £4M in venture funding in March of 2019, a few months after the company introduced its HeartKey portfolio. Nymi has also leveraged heart rate biometrics for passive authentication with its flagship Nymi Band.

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(Originally posted on Mobile ID World)