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HeartBeam, Inc.

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Press Releases

News & Events

News & Events

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Dec 10, 2025 7:00am EST

HeartBeam Receives FDA Clearance for First-Ever, Cable-Free Synthesized 12-Lead ECG for At-Home Arrhythmia Assessment

Nov 26, 2025 4:32pm EST

HeartBeam Provides Update on Regulatory Path Following FDA Decision on 12-Lead ECG Synthesis Software Application

Nov 13, 2025 4:01pm EST

HeartBeam Reports Third Quarter 2025 Results

Oct 30, 2025 7:00am EDT

HeartBeam to Host Third Quarter 2025 Results Conference Call on Thursday, November 13, 2025 at 4:30 p.m. Eastern Time

Oct 28, 2025 7:00am EDT

HeartBeam Teams Up With HeartNexus to Deliver Cardiologist-Level ECG Insights Anytime, Anywhere

Sep 08, 2025 7:00am EDT

HeartBeam’s Deep Learning Algorithms Demonstrate High Rates of Accuracy for Detecting Arrhythmias

Aug 28, 2025 7:00am EDT

HeartBeam to Participate at Upcoming Industry and Investor Conferences, September 4-10, 2025

Aug 13, 2025 4:01pm EDT

HeartBeam Reports Second Quarter 2025 Results

Jul 30, 2025 7:00am EDT

HeartBeam to Host Second Quarter 2025 Results Conference Call on Wednesday, August 13, 2025 at 4:30 p.m. Eastern Time

Jul 22, 2025 7:00am EDT

HeartBeam Wins Industry Innovation Award for Advancing Remote Cardiac Care With Groundbreaking ECG Technology

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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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