HeartBeam Receives FDA Clearance

December 16, 2024

DENVER, Colo., Dec 16, 2024 (247marketnews.com)- HeartBeam (NASDAQ: BEAT) stated that the US Food and Drug Administration (FDA) granted the HeartBeam system 510(k) clearance for comprehensive arrhythmia assessment and the Company will initiate an Early Access Program to gain vital patient and physician feedback, in preparation for commercial launch.

The HeartBeam device is a high-fidelity electrocardiogram (ECG) system that captures heart signals from three distinct directions for actionable heart health information and is the first-of-its-kind to receive FDA clearance.

Robert Eno, HeartBeam’s CEO, commented, “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. 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.”

To view HeartBeam System video

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