HeartBeam's Credit-Card-Sized ECG Device Receives FDA Clearance for Portable Arrhythmia Assessment

HeartBeam Inc. (NASDAQ: BEAT) has developed a credit-card-sized electrocardiogram (ECG) device that captures three-dimensional cardiac signals to synthesize a full 12-lead output, providing hospital-level arrhythmia evaluation in portable form. The device, cleared by the FDA in December 2024, is designed for patients to carry in wallets or purses for on-demand readings, enabling cardiac monitoring outside traditional medical facilities.

CEO Rob Eno explained the technology's functionality, stating that the device records signals in three dimensions—up-down, side-to-side, and front-to-back—which the company's proprietary algorithm converts into a comprehensive 12-lead ECG. This innovation represents a significant advancement in portable cardiac monitoring technology, allowing patients to obtain clinical-grade ECG readings wherever they are located. The company expects to receive FDA clearance for its algorithm later this year, further enhancing the device's capabilities.

The coverage also highlights HeartBeam's strategic partnership with AccurKardia to integrate FDA-cleared AccurECG software for automated rhythm interpretation and streamlined physician workflows. This integration enables patients to use the accompanying application for both routine monitoring and symptom-triggered recordings, with data automatically routed to on-call cardiologists when necessary. The combination of portable hardware and sophisticated software creates a comprehensive remote cardiac monitoring solution that could significantly improve patient outcomes through early detection and intervention.

While reimbursement pathways for the technology are still developing, HeartBeam intends to focus its commercial strategy on preventive cardiology and concierge medical practices. The company has additional research underway to expand adoption and demonstrate the technology's cost-effectiveness in various healthcare settings. This approach recognizes the growing importance of remote patient monitoring and preventive care in modern healthcare systems, particularly as populations age and cardiovascular disease remains a leading cause of mortality worldwide.

The technology's potential impact extends beyond individual patient care to broader healthcare system efficiency. By enabling accurate cardiac assessment outside medical facilities, the device could reduce unnecessary emergency department visits, lower healthcare costs, and improve access to cardiac care for patients in remote or underserved areas. The company holds over 20 issued patents related to this technology, protecting its innovations in three-dimensional ECG signal capture and analysis. More information about HeartBeam's developments is available at https://ibn.fm/BEAT.