HeartBeam Wins FDA Nod for Home High-Fidelity Heart Monitor

HeartBeam has earned U.S. Food and Drug Administration (FDA) 510(k) clearance of its system for comprehensive arrythmia assessment. According to the company, the HeartBeam device is the first of its kind to receive FDA clearance.

The high-fidelity electrocardiogram (ECG) system is the size of a credit card and has a cable-free design. It captures heart signals from three distinct directions to provide actionable heart health information.

When a patient feels symptoms, the HeartBeam patient app guides them through placement of the device on the chest and collecting a 30-second recording. Once the recording is captured, signals are sent to the cloud, processed, and transmits to a physician for review. The physician reviews the ECG recording in the context of the patient’s symptoms and medical history and follows up with the patient about the next steps.

HeartBeam said it plans to begin an Early Access Program and is creating a waitlist of interested patients and clinicians.

“It’s well documented that patients who delay seeking care for their cardiac symptoms face worse clinical outcomes. The ability for patients to capture high-fidelity ECG signals from three directions wherever they are when symptoms occur will help patients get the care they need in a timelier manner,” said Robert Eno, CEO of HeartBeam. “The FDA clearance of our technology is a significant milestone for the Company that brings us one step closer to fulfilling our vision of providing unprecedented cardiac insights to individuals and physicians.”

This FDA clearance, according to the company, is foundational and will be the basis for future submissions as it aims to simplify access of intelligent, actionable 12-lead ECGs. Future planned updates include a synthesized 12-lead ECG, AI-based classification algorithms, and heart attack detection.

HeartBeam released results from two studies evaluating its vector-based technology during the American Heart Association’s annual Scientific Sessions last month.