BioMedNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Submits FDA Application for 12-Lead ECG Synthesis Software

HeartBeam (NASDAQ: BEAT), a medical technology company advancing cardiac care, has submitted a 510(k) application to the U.S. Food and Drug Administration (“FDA”) for its 12-lead electrocardiogram (“ECG”) synthesis software. The software is designed to assess cardiac rhythms and arrhythmias, including atrial fibrillation, atrial flutter, bradycardia, and tachycardia. The submission is supported by data from the VALID-ECG pivotal study, which enrolled 198 patients across five clinical sites and demonstrated clinical equivalence to standard 12-lead ECGs.

HeartBeam recently secured FDA clearance for its patented technology that captures heart signals from three directions and synthesizes them into a traditional 12-lead ECG format. Upon approval, the company plans a commercial launch informed by its Early Access Program, which has already attracted strong physician and patient interest.

CEO Robert Eno highlighted the software’s potential to transform cardiac monitoring outside medical facilities. Future advancements include AI-driven classification algorithms and heart attack detection to reduce “symptom to door” times, a key focus for the American Heart Association.

To view the full press release, visit https://ibn.fm/ngFZe

About HeartBeam Inc.

HeartBeam is a medical technology company dedicated to transforming cardiac care by providing powerful cardiac insights wherever the patient is. The company is creating the first-ever cable-free 12-lead ECG capable of capturing the heart’s electrical signals from three dimensions. This platform technology is designed to be used in 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. The company holds 13 U.S. and 4 international-issued patents related to technology enablement. 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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