Belfast tech firm B-Secur announced it has received US Food and Drug Administration (FDA) approval for its ECG heart monitoring software.
Alan Foreman, CEO at B-Secur commented: “Securing FDA clearance is a real game changer for B-Secur and for heart health innovation worldwide. For the first time, companies making consumer wearable devices or equipment for the healthcare sector can now generate advanced medical-grade wellness and health data from any device and platform.
"It was a rigorous process to go through and involved a significant number of participants, but it will have a radical impact on the medtech and healthcare sectors as well as on our growth ambitions as a business. Right now, a key focus is on the US market with recruitment currently underway to support demand across the growing med-tech and consumer wellness markets.”
With HeartKey®, ECG is used to determine who you are and how you are at the same time, and B-Secur says it can help protect lives, data, and devices.
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Cardiovascular disease (CVD) is the number one cause of death globally with an estimated 17.9m people dying from the disease each year, representing 31% of all deaths worldwide.
In the last year, the Covid-19 pandemic has led to additional complications for those with underlying heart conditions. The virus has also caused irreparable cardiac damage and arrhythmias in people with no underlying heart issues, making heart health and remote monitoring a key priority for patients, clinicians and health service providers around the world.
Headquartered at Belfast's Catalyst in The Innovation Center, B-Secur is "on a mission to revolutionise the way people experience technology in the connected world using their unique heartbeat".
The company employs 35 engineers and has invested many years of advanced, scientific research in ECG, partnering with global tech firms.
The FDA Clearance development enables the company to proactively target the global telemedicine market which was valued at $45bn in 2019, as well as the global wearables market valued at $32.63bn.
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Source: Written from press release
