HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, has begun enrolling the first patients in its VALID-ECG pivotal study. According to the announcement, the first patients were enrolled at Atlanta Heart Specialists, a top cardiology physician practice in Atlanta, Georgia. HeartBeam anticipates the VALID-ECG study will form the basis of its planned FDA 510(k) submission. The study is designed to evaluate the performance of a 12-lead ECG synthesized from the credit-card-sized HeartBeam AIMIGo(TM) system compared to a standard hospital-based 12-lead ECG; the study will use both quantitative and qualitative methodologies for assessment of arrhythmias. The company anticipates enrolling some 198 patients in the program. “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,” said HeartBeam CEO and founder Branislav Vajdic, PhD, in the press release. “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.”
To view the full press release, visit https://ibn.fm/KDs3L
About HeartBeam Inc.
HeartBeam is a medical technology company dedicated to transforming cardiac care through the power of personalized insights. The company’s proprietary vectorelectrocardiography (“VECG”) technology collects 3D signals of the heart’s electrical activity and converts those signals into a 12-lead ECG. This platform technology is designed to be used on portable, patient-friendly devices such as a credit-card-sized monitor, watch or patch. 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 how cardiac health is managed. For more information, visit www.HeartBeam.com.
NOTE TO INVESTORS: The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT
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