NetworkNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT
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- 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.
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