B-Secur has announced the US Food and Drug Administration (FDA) clearance and launch of HeartKey Rhythm—a suite of electrocardiogram (ECG) algorithms and analytics designed to enhance clinical confidence, streamline industry efficiency, and improve outcomes for cardiac patients.
Powered by B-Secur’s innovative signal processing engine, HeartKey Rhythm enhances signal clarity by reducing noise to deliver high-quality ECG data. Specifically targeted at the ambulatory ECG (AECG) market, HeartKey Rhythm’s rhythm detection algorithms and signal quality indicators allow clinicians to prioritise their interpretation of data and enable more confident detection of actionable cardiac conditions—as stated in a B-Secur press release.
“Achieving FDA clearance for our latest product, HeartKey Rhythm, is a monumental step toward helping providers deliver more timely, efficient and preventative care,” said Alan Foreman, chief executive officer and co-founder of B-Secur. “This marks our second FDA clearance in just four years, highlighting our relentless drive for innovation and commitment to rapidly bringing impactful solutions to the market.
“One person dies every 33 seconds from cardiovascular disease (CVD) in the USA and, by 2050, the total cost of CVD is expected to triple, reaching US$1.851 trillion. These figures are frankly alarming, and underscore the urgent need for technological solutions that drive efficiencies and enable proactive monitoring.”
B-Secur claims that, alongside the two concurrent challenges of rising costs and an increasing prevalence of CVD, the healthcare sector also faces another threat: a growing shortage of cardiologists and electrophysiologists. While ECG readings are foundational to cardiac diagnosis and care, they have traditionally been compromised by noise contamination, which limits their usability. The company’s recent release notes that nearly 42% of healthcare professionals say that remote ECGs often require additional testing to confirm results, and 53% find these readings difficult to interpret.
“There is an ever-increasing reliance on ECG data collected outside of a controlled clinical environment,” said Adrian Condon, B-Secur’s chief technology officer and co-founder. “Our breakthrough FDA-cleared product, HeartKey Rhythm, significantly improves the ECG signal processing and rhythm recognition of ambulatory devices and platforms.”
The release adds that, in addition to AECG 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. However, the ability to keep pace with this volume depends on the accuracy and efficiency of ECG interpretation. While HeartKey Rhythm is focused on AECG, B-Secur states that it also offers on-chip solutions designed for consumer wearable devices, further supporting the convergence of these technologies in the fight against heart disease.
