Belfast biometrics firm B-Secur has been given regulatory approval to launch and sell its innovative heart monitoring technology in the lucrative US market.
It has secured clearance from the powerful Food and Drug Administration (FDA) to launch its HeartKey Rhythm, a suite of electrocardiogram (ECG) algorithms and analytics designed to enhance clinical confidence, streamline industry efficiency, and improve outcomes for cardiac patients - effectively keeping people alive.
It’s B-Secur’s second FDA clearance in just four years, highlighting it relentless drive for innovation and commitment to rapidly bringing impactful solutions to the market.
“Achieving FDA clearance for our HeartKey Rhythm product is a monumental step toward helping providers deliver more timely, efficient and preventative care,” said Alan Foreman, chief executive and co-founder of B-Secur.
“One person dies every 33 seconds from cardiovascular disease in the US, and by 2050, the total cost of CVD is expected to triple, reaching more than $1.8 trillion.
“These figures are frankly alarming and underscore the urgent need for technological solutions that drive efficiencies and enable proactive monitoring.”
Powered by B-Secur’s innovative signal processing engine, HeartKey Rhythm enhances signal clarity by reducing noise, delivering high-quality ECG data.
Its rhythm detection algorithms and signal quality indicators allow clinicians to prioritize their interpretation of data and enable more confident detection of actionable cardiac conditions.
“There is an ever-increasing reliance on ECG data collected outside of a controlled clinical environment,” said Adrian Condon, chief technical officer and co-founder at B-Secur, whose offices are in City Quays 3 in Belfast.
“Our breakthrough FDA cleared product, HeartKey Rhythm, significantly improves the ECG signal processing and rhythm recognition of ambulatory devices and platforms.”
Founded in 2002, B-Secur has developed a world first software technique that uses an individual’s unique heartbeat pattern and provide health and wellness insights at the same time.
In addition to ambulatory ECG devices, the rise of consumer wellness wearables such as smartwatches and rings equipped with ECG capabilities, is generating an influx of data that device manufacturers can use to empower healthcare providers.
While HeartKey Rhythm is focused on ambulatory ECG, B-Secur also offers on-chip solutions designed for consumer wearable devices, further supporting the convergence of these technologies in the fight against heart disease.
B-Secur is backed by Orlando Health, a US hospital and healthcare organization recognised by Fortune as one of America’s most innovative companies in 2024.
