HeartBeam, a California-based healthcare startup, is now enrolling patients for a new pivotal study of its AIMIGo system, a portable heart monitor designed to provide on-the-go heart attack detection by synthesizing 12-lead electrocardiograms (ECGs).
The AIMIGo device is approximately the size of a credit card and uses the company’s patented 3D vectorelectrocardiography (3D VECG) technology to capture signals from three different projections and deliver a synthesized 12-lead ECG. A smartphone app guides the patient through the entire capture process, and on-call cardiologists review the ECG results as data are transmitted to the cloud.
The VALID-ECG study will enroll 198 patients total, comparing the performance of HeartBeam’s 12-lead ECGs with standard 12-lead ECGs. The first patients enrolled for the study were identified by cardiologists with Atlanta Heart Specialists in Georgia.
“The initiation of the VALID-ECG study is a major milestone for the company and a reflection of our commitment to provide a strong foundation of clinical data as we strive to provide patients and physicians with the ability to accurately monitor cardiac disease outside of a medical facility,” Branislav Vajdic, PhD, CEO and founder of HeartBeam, said in a statement. “In addition, our product pipeline includes coupling AI with our data-rich 3D VECG technology which will enable us to extract unique information and longitudinal insights to transform how cardiac care is monitored in the future.”
“We are thrilled to be part of this important study as AIMIGo represents a significant leap in cardiac monitoring technology,” added David D. Suh, MD, director of research at Atlanta Heart Specialists. “It brings the power of 3D VECG into a familiar 12-lead ECG waveform which is used to evaluate a range of cardiac conditions on a daily basis.”
HeartBeam hopes to use data from VALID-ECG when it submits its 510(k) application for U.S. Food and Drug Administration approval. The company already completed a pilot study it hopes to present to the public in the months ahead.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.