HeartBeam (NASDAQ: BEAT) has received FDA 510(k) clearance for its groundbreaking HeartBeam system, a credit card-sized, cable-free ECG device designed for comprehensive arrhythmia assessment. The system enables patients to record high-fidelity heart signals from three directions during symptoms, with data transmitted to physicians for timely review and action. This milestone marks the first FDA-cleared device of its kind and lays the foundation for future advancements, including synthesized 12-lead ECGs, AI-driven arrhythmia detection, and heart attack risk assessment. HeartBeam aims to transform cardiac care by delivering actionable insights and predictive diagnostics for patients and physicians globally.
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About HeartBeam Inc.
HeartBeam is a medical technology company dedicated to transforming cardiac care by providing powerful cardiac insights wherever the patient is. The company is creating the first-ever cable-free 12-lead ECG capable of capturing the heart’s electrical signals from three dimensions. This platform technology is designed to be used in portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care — all outside of a medical facility, thus redefining the future of cardiac health management. The company holds 13 U.S. and 4 international-issued patents related to technology enablement. For more information, visit www.HeartBeam.com .
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