HeartBeam, Inc.
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- HeartBeam, Inc. is a medical technology company focused on transforming cardiac care through advanced ambulatory electrocardiogram (ECG) solutions. The company develops and commercializes a portable, cable-free 3D ECG device that captures heart signals from three non-coplanar dimensions and synthesizes these into a standard 12-lead ECG. HeartBeam’s product offerings include this handheld ECG device and its related 12-lead ECG synthesis software, designed to enable high-fidelity heart data collection from patients outside medical facilities. The platform is supported by cloud-based diagnostic expert software that provides actionable cardiac insights for physicians. The company’s technology is FDA cleared for arrhythmia assessment as of December 2024 and has over 20 patents related to its innovations. HeartBeam targets cardiac patients in ambulatory and telehealth settings, aiming to improve early detection and management of cardiac conditions such as arrhythmias and ischemic events. Headquartered in Santa Clara, California, the company operates primarily in the United States. In the last two years, HeartBeam has made significant progress in regulatory and strategic areas. Its 12-lead ECG synthesis software is currently under FDA review after a Not Substantially Equivalent (NSE) decision on its 510(k) submission, with ongoing constructive dialogue for resolution including possible appeal or resubmission pathways. HeartBeam has also entered strategic collaborations to enhance its platform’s capabilities, notably partnering with AccurKardia to integrate FDA-cleared automated ECG interpretation software into HeartBeam’s devices to improve remote cardiac monitoring accessibility. Additionally, the company forged a partnership with HeartNexus to provide cardiologist-level ECG interpretation on demand, further expanding its telemedicine and remote diagnostic services. These developments align with HeartBeam’s goal to redefine cardiac health management by enabling actionable heart intelligence outside of traditional clinical settings. Founded in 2013, HeartBeam operates within the medical technology industry, focusing on cardiac monitoring devices and diagnostic software. The company serves healthcare providers and cardiac patients requiring remote, ambulatory monitoring across the United States, leveraging innovations in ECG technology to support early diagnosis and timely treatment. Its solutions address critical gaps in cardiac care by combining portable hardware with cloud-based software and expert telemedicine services, positioning HeartBeam as a notable player in the growing field of digital health and cardiac care technology. This combination of proprietary 3D ECG hardware, sophisticated ECG synthesis software under regulatory review, strategic partnerships enhancing diagnostic capabilities, and a cloud-based connected cardiac care ecosystem defines HeartBeam’s comprehensive product and service portfolio. It strives to empower physicians with detailed cardiac health trends and acute condition identification, enabling improved patient outcomes beyond hospital settings. HeartBeam’s headquarters are located in Santa Clara, California, United States, where it continues to advance its mission of transforming cardiac care through technological innovation and strategic collaborations in the remote cardiac monitoring space.
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