BELFAST firm B-Secur, which commercialises the application of patented ECG algorithms for a range of uses, has received US Food and Drug Administration (FDA) for its potentially life-saving HeartKey software in what it says is “a significant breakthrough for our global growth”.
The key development in heart health provides the potential for consumer wearables such as smart watches and for medical device manufacturers to access advanced medical-grade data from any device and platform.
It will allow B-Secur - which has offices in Belfast’s Innovation Centre employing 35 scientists and engineers - to proactively target the $45 billion global telemedicine market as well as the $32 billion wearables market.
The firm's chief executive Alan Foreman said: “This 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.”
He added: “It was a rigorous process to go through and involved a significant number of participants, but it will have a radical impact on the med-tech 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.”
B-Secur has invested a number of years of advanced scientific research in atrial fibrillation heart condition, which impacts more than 30 million people worldwide, and has become a global leader in the development and integration of ECG technology.
