FDA Clears B-Secur’s HeartKey Rhythm Solution for Proactive, Effective Cardiac Care

B-Secur, a leader in advanced biosensing technology, has received FDA clearance and launched 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.
 
“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, CEO 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.”
 
 HeartKey Rhythm enhances signal clarity by reducing noise and delivers high-quality ECG data. It is specifically targeted at the ambulatory ECG (AECG) market, and HeartKey Rhythm’s 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, B-Secur’s CTO and Co-founder. “Our breakthrough FDA-cleared product, HeartKey Rhythm, significantly improves the ECG signal processing and rhythm recognition of ambulatory devices and platforms.”
 
While HeartKey Rhythm is focused on AECG, 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 U.S. Hospital.