The purpose of this study was to evaluate whether the 12-lead ECG could be substituted by ECG sets with a limited number of leads. Materials and methods: The performance of three ECG systems (ie ...
"This landmark study provides compelling clinical evidence ... performed comparably to the standard 12-lead ECG in detecting major morphology-related abnormalities, including bundle branch blocks ...
The Company believes the study's findings support the clinical equivalence of HeartBeam's synthesized 12-lead ECG where the leads are similar to standard 12-lead ECGs for rhythm and arrhythmia ...
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HeartBeam submits 510(k) application to FDA for ECG softwareHeartBeam has submitted a 510(k) application to the US Food and Drug Administration (FDA) for its 12-lead electrocardiogram ...
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AI-driven ECG age prediction transforms early disease detectionAI-enabled ECG biological age (ECG-BA) improves disease risk classification beyond chronological age, enhancing early ...
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 ( ...
The FDA submission is backed by robust data from the VALID-ECG pivotal study, which enrolled 198 patients across five ...
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