HeartBeam has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s “groundbreaking” 12-lead electrocardiogram (ECG) synthesis software for the assessment of arrhythmias. This clearance follows HeartBeam’s successful appeal of a prior Not Substantially Equivalent (NSE) determination, according to a company press release.
“One of the biggest challenges in cardiology is that cardiac symptoms most often don’t happen in the doctor’s office—they happen at home, at night, at work,” said Robert Harrington (Weill Cornell Medicine, New York, USA), a HeartBeam scientific advisory board member. “The ability for patients to collect clinically meaningful ECG data at that exact moment, not hours later, can allow physicians to gain a much clearer understanding of a patient’s condition and take more timely action. HeartBeam is designed to be easy to carry and easy for patients to use, representing an important step forward in cardiac care.”
HeartBeam claims that—unlike any single- or six-lead consumer device—its patented cable-free technology captures the heart’s electrical signals in three non-coplanar dimensions, and synthesises them into a 12-lead ECG representation. This allows patients to obtain an ECG reading for their arrhythmia “from the comfort of home, or wherever they happen to be, representing a new level of convenience and peace of mind”. As part of this process, the synthesised 12-lead ECG is promptly reviewed by an on-demand, board-certified cardiologist, the company adds.
With this US FDA clearance, HeartBeam intends to advance several key initiatives as part of its growth strategy, including initiating a limited market release in early 2026, pursuing a heart attack detection indication, advancing the on-demand 12-lead ECG extended wear monitor project, and unlocking the power of the unique data-rich repository generated from its 3D ECG platform.
“The company wishes to thank the US FDA for its expeditious and constructive engagement throughout the review and appeal process, as well as its thorough evaluation of HeartBeam’s clinical data,” said HeartBeam chief executive officer (CEO) Robert Eno. “This US FDA clearance is a defining moment for HeartBeam, and the true beginning of our mission to revolutionise cardiac care. We look forward to initiating our US market introduction while advancing our efforts on heart attack detection, an on-demand 12-lead extended wear patch, and AI [artificial intelligence]-based screening and prediction algorithms trained on our unique longitudinal data.”
