FDA-cleared technology makes clinical-grade ECG insights for arrhythmia assessment available outside of a medical facility

SANTA CLARA, Calif., July 22, 2025--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced it has been awarded the Innovation Award in Remote Cardiac Diagnostics as part of the 2025 Medical Device Network Excellence Awards. The award honors HeartBeam’s groundbreaking, FDA-cleared electrocardiogram (ECG) technology that enables clinical-grade diagnostics for arrhythmia assessment outside of traditional healthcare settings, expanding access to timely and actionable cardiac care.

The Medical Device Network Excellence Awards, powered by GlobalData’s business intelligence, is one of the most respected independent recognition programs in the industry. The program analyzes over one billion datasets annually to recognize forward-thinking companies that drive positive change and set new standards for excellence across the global medical device sector.

The award recognizes HeartBeam’s proprietary 3D ECG technology which captures the heart’s electrical signals in 3 distinct, non-coplanar directions and then synthesizes these signals into a 12-lead ECG. The technology makes it possible to provide diagnostic fidelity similar to a standard 12-lead ECG in a credit card-sized, cable-free device which enables patients to record their arrhythmia symptoms the moment they occur. The 12-lead ECG synthesis software is currently under review by FDA, and upon FDA clearance, HeartBeam plans to initiate commercialization.

"This recognition affirms our vision of transforming how cardiac conditions are monitored and detected and validates our belief that access to high-fidelity ECG data should not be limited by healthcare settings," said Robert Eno, Chief Executive Officer of HeartBeam. "As we continue to prepare for the market introduction of the HeartBeam System, this award highlights our leadership position in delivering clinically validated, patient-centric solutions to advance remote cardiac care."

The Medical Device Network Excellence Award adds to the growing body of industry recognitions HeartBeam has received, including the Pinnacle Healthcare Award, Digital Health Hub Foundation Award, and MedTech Breakthrough Award.

About HeartBeam, Inc.

HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company is creating the first-ever cable-free device capable of collecting ECG signals in 3D, from three non-coplanar directions, and synthesizing the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management. HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024. The 12-Lead ECG synthesis software is under FDA review. The Company holds over 20 issued patents related to technology enablement. For additional information, visit HeartBeam.com.



Forward-Looking Statements

All statements in this release that are not based on historical fact are "forward-looking statements." While management has based any forward-looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our Forms 10-K, 10-Q and other reports filed with the SEC and available at www.sec.gov. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

Cleared Indications for Use

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. For full safety information, see the full Instructions for Use or Clinician Portal Manual.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250722113026/en/

Contacts

Investor Relations Contact: 
Chris Tyson
Executive Vice President
MZ North America
Direct: 949-491-8235
[email protected] 
www.mzgroup.us

Media Contacts: HeartBeam: [email protected]