HeartBeam Inc. has developed a credit-card-sized electrocardiogram device that captures three-dimensional cardiac signals to synthesize a full 12-lead output, providing hospital-level arrhythmia evaluation outside traditional clinical environments. The portable system, cleared by the FDA in December 2024, is designed for patients to carry in wallets or purses for on-demand readings, representing a significant advancement in remote cardiac monitoring technology. CEO Rob Eno explained that the device records signals from three non-coplanar directions—up-down, side-to-side, and front-to-back—which the company's proprietary algorithm converts into a comprehensive 12-lead ECG. This technology enables patients to capture clinical-grade cardiac data whenever symptoms occur or for routine monitoring, with the company expecting FDA clearance for the synthesis algorithm later this year.
The device's compact size and portability address a critical gap in cardiac care by allowing immediate ECG capture during symptomatic episodes that might otherwise go unrecorded. HeartBeam has partnered with AccurKardia to integrate its FDA-cleared AccurECG software for automated rhythm interpretation and streamlined physician workflows. This integration allows patients to use the accompanying application for both scheduled and symptom-triggered recordings, with data automatically routed to on-call cardiologists when necessary. The combination of portable hardware and sophisticated software creates a complete ecosystem for remote cardiac monitoring that could significantly reduce time to diagnosis and treatment for arrhythmia patients.
While reimbursement pathways for the technology are still developing, HeartBeam intends to focus its initial commercial strategy on preventive cardiology and concierge medical practices. The company is conducting additional research to expand adoption and demonstrate the technology's cost-effectiveness in various healthcare settings. This approach recognizes the growing importance of remote patient monitoring in value-based care models and the increasing demand for technologies that can deliver hospital-grade diagnostics outside traditional healthcare facilities.
The implications of this technology extend beyond individual patient convenience to potentially transform cardiac care delivery patterns. By enabling reliable ECG capture in non-clinical environments, the device could reduce emergency room visits, facilitate earlier intervention for cardiac events, and provide cardiologists with more comprehensive data for treatment decisions. The technology's ability to capture 3D signals and synthesize them into standard 12-lead formats represents a significant technical achievement that bridges the gap between portable monitoring and clinical-grade diagnostics.
