HeartBeam Unveils Credit-Card ECG Device with FDA Arrhythmia Clearance
BEAT•HeartBeam’s cable-free, credit-card sized ECG system captures three-dimensional cardiac signals and synthesizes 12-lead data to improve pre-hospital arrhythmia assessment. The FDA-cleared platform, which requires no adhesive patches, holds 13 U.S. and 4 international patents and is set for a future indication expansion to heart attack detection.
1. Technology Innovation
HeartBeam has developed a cable-free ECG platform that uses embedded electrodes in a compact, credit-card sized device. By capturing the heart’s electrical signals from three distinct directions, the system generates synthesized 12-lead ECG data for a more comprehensive assessment than traditional single-lead monitors.
2. Regulatory Status
The HeartBeam System is currently cleared by the FDA for arrhythmia assessment, enabling clinicians to access clinical-grade cardiac data outside hospital settings. Its design eliminates adhesive patches and wires, simplifying user experience while maintaining high-fidelity signal quality.
3. Patent Portfolio and Future Plans
The company holds 13 U.S. and 4 international-issued patents covering its multidirectional ECG technology. HeartBeam plans to submit for an expanded FDA indication to detect myocardial infarction, aiming to address critical gaps in early cardiac event detection.
