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HeartBeam, Inc.

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News & Events

News & Events

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October 29, 2025

HeartBeam has been recognized as a Global IP and Technology Leader in Portable Cardiac Diagnostics in a new report by PatentVest

August 26, 2025

Medical Device and Diagnostic Industry: HeartBeam’s Algorithm Synthesizes a 12-Lead ECG Output in a Credit-Card-Sized Device

February 13, 2025

Cardiovascular Business: HeartBeam raising $10M for FDA-cleared health tech with public offering

February 13, 2025

Stock Titan: HeartBeam Announces Pricing of $10.0 Million Underwritten Public Offering of Common Stock

February 13, 2025

Morningstar: HeartBeam Announces Pricing of $10.0 Million Underwritten Public Offering of Common Stock

January 30, 2025

Medical Device Network: HeartBeam submits 510(k) application to FDA for ECG software

January 29, 2025

Investing.com: HeartBeam seeks FDA nod for ECG synthesis software

December 18, 2024

Cardiac Rhythm News: HeartBeam announces US FDA clearance for at-home, high-fidelity heart monitoring technology

December 17, 2024

EP Lab Digest: HeartBeam Announces FDA Clearance for At-Home, High-Fidelity Heart Monitoring Technology

December 17, 2024

Cardiovascular Business: FDA clears credit card-sized heart monitor

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The HeartBeam System is a portable non-invasive recorder intended to record, store, and transfer a patient’s 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. 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 and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional.

The HeartBeam 12-Lead ECG Synthesis Software synthesizes a 12-Lead ECG from the HeartBeam System 3-Leads (in three-directions) recording device, producing a visual 12-Lead ECG representation that is similar, but not identical, to the same leads of a standard diagnostic 12-Lead ECG. The synthesized 12-Lead ECG output is solely intended for manual assessment of normal sinus rhythm and the following non-life-threatening arrhythmias: sinus arrhythmia, sinus tachycardia, sinus bradycardia, atrial premature complexes, atrial fibrillation, and ventricular premature complex. The synthesized 12-Lead ECG output is not intended for the assessment of any other arrhythmia or conditions (including but not limited to: other atrial arrhythmias, ventricular arrhythmias, hypertrophy, conduction disorders, myocardial infarction or ischemia, pacemaker functions, localization of arrhythmia foci, ECG wave abnormalities, and/or any other disorder). The software does not conduct cardiac analysis and is not intended to replace a standard 12-Lead ECG. The 12-Lead ECG Synthesis Software is intended for adult use only. For full safety information, see the full Instructions for Use or Clinician Portal Manual.

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