HeartBeam’s At-Home Heart Monitoring Technology Cleared by FDA

December 16, 2024—HeartBeam, Inc. announced FDA 510(k) clearance of the HeartBeam system for comprehensive arrhythmia assessment.

The HeartBeam system is a portable noninvasive recorder intended to record, store, and transfer a patient’s three-lead electrocardiogram (ECG) acquired from five electrodes. The high-fidelity ECG system captures heart signals from three distinct directions for actionable heart health information. The system features a credit card-sized form factor and cable-free design, noted the company.

According to HeartBeam, the device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis. It can be used with an ECG viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or health care professional.

HeartBeam plans to initiate an early access program and is creating a waitlist of interested patients and physicians, noted the press release.

The FDA clearance will serve as the basis for future submissions. Planned advances include a synthesized 12-lead ECG; artificial intelligence-based classification algorithms; and heart attack detection, stated the company.