HeartBeam (NASDAQ: BEAT) has announced that the FDA has granted 510(k) clearance for its first-ever, cable-free, 12-lead electrocardiogram (ECG) synthesis software for the at-home assessment of arrhythmias.
According to HeartBeam, this clearance follows HeartBeam’s successful appeal of a prior Not Substantially Equivalent (NSE) determination.
In a statement, Robert Eno, CEO of HeartBeam commented, “The company wishes to thank the FDA for its expeditious and constructive engagement throughout the review and appeal process, as well as its thorough evaluation of HeartBeam’s clinical data.”
He added, “This FDA clearance is a defining moment for HeartBeam, and the true beginning of our mission to revolutionize cardiac care. We look forward to initiating our U.S. market introduction while advancing our efforts on heart attack detection, an on-demand 12-lead extended wear patch, and AI-based screening and prediction algorithms trained on our unique longitudinal data.”
Robert A. Harrington, MD, world-renowned cardiologist and HeartBeam scientific advisory board member, remarked, “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. 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.”
