HeartBeam Announces FDA Submission of HeartBeam AIMIGo™ VECG System

May 18, 2023 |

3 min read

HeartBeam, Inc. today announced it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its HeartBeam AIMIGo™ System.

Submission Seeks Clearance for the Company’s 3D Vector Electrocardiogram Device

SANTA CLARA, Calif.--(BUSINESS WIRE)-- HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D vector electrocardiogram (VECG) platform intended for patient use at home, today announced it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its HeartBeam AIMIGo™ System.

HeartBeam has developed the HeartBeam AIMIGo System, a personal, portable and easy-to-use VECG solution to assist patients and their clinicians in assessing cardiac symptoms. HeartBeam’s breakthrough solution employs a reusable, credit card-sized, VECG recording device and cloud-based software to deliver critical data to clinicians in real-time outside of a medical setting. More than 127 million people in the U.S. have cardiovascular disease, including more than 20 million with coronary artery disease.

“The 510(k) submission of our HeartBeam AIMIGo VECG device is an important milestone for the company,” said Branislav Vajdic, Ph.D., HeartBeam CEO and founder. “We believe that our patented VECG technology holds tremendous promise to provide timely and actionable information to patients and their clinicians. This submission is the result of years of hard work to develop and refine the technology. I am extremely proud of our team and all their efforts to get the product to this stage. We look forward to working with the FDA as they review this application.

“This year is pivotal for HeartBeam. In addition to this FDA submission, we are undertaking clinical studies on the system’s ability to synthesize a 12-lead ECG from our VECG signal, providing clinicians with the output that they expect in evaluating cardiac patients. Our recently announced $26.5 million capital raise will allow us to accelerate our clinical studies and activities related to our FDA submissions,” added Vajdic.

About HeartBeam, Inc.

HeartBeam, Inc. (NASDAQ: BEAT) is a cardiac technology company that has developed the first and only 3D-vector ECG platform intended for patient use at home. By applying a suite of proprietary algorithms to simplify vector electrocardiography (VECG), the HeartBeam platform enables patients and their clinicians to assess their cardiac symptoms quickly and easily, so care can be expedited, if required. HeartBeam has two patented products in development. HeartBeam AIMI™ is software for acute care settings that provides a 3D comparison of baseline and symptomatic 12-lead ECG to more accurately identify a heart attack. HeartBeam AIMIGo™ is the first and only credit card-sized 12-lead output ECG device coupled with a smart phone app and cloud-based diagnostic software system to facilitate remote evaluation of cardiac symptoms. HeartBeam AIMI and AIMIGo have not yet been cleared by the U.S. Food and Drug Administration (FDA) for marketing in the USA or other geographies. For more 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 in 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.