- HeartBeam’s credit card-sized device demonstrated 93.4% diagnostic agreement with standard ECGs
- VALID-ECG study results presented at Heart Rhythm Society conference
- Company eyes U.S. commercialization pending FDA clearance
HeartBeam (NASDAQ: BEAT) announced its synthesized 12-lead ECG met clinical endpoints in the VALID-ECG pivotal study, achieving 93.4% diagnostic agreement with standard ECGs for arrhythmia assessment. The findings, presented by Dr. Thomas Deering of Piedmont Heart Institute at the Heart Rhythm Society’s annual meeting in San Diego, validate HeartBeam’s compact, patient-friendly ECG technology.
The study compared ECG intervals and amplitudes between HeartBeam’s synthesized output and simultaneously collected standard ECGs in 198 patients across five U.S. clinical sites. The results support the company’s FDA submission for its ECG synthesis software, filed in January 2025.
CEO Robert Eno emphasized the significance of enabling accurate, on-demand arrhythmia monitoring outside medical facilities. With FDA clearance anticipated, HeartBeam has launched an Early Access Program to refine clinical workflows and prepare for U.S. market entry.
To view the full press release, visit https://ibn.fm/XMuzZ
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
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