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more on BEAT HeartBeam, pilot study shows its patient-recorded 3D ECG matched a standard 12-lead ECG for heart attack assessment — Specificity 81.8% v
Nov 2, 2026 · ThinkSabio Blog
more on BEAT
HeartBeam, pilot study shows its patient-recorded 3D ECG matched a standard 12-lead ECG for heart attack assessment — Specificity 81.8% vs 71.4% for the 12-lead, sensitivity comparable at 60.2% vs 63.0% — All patients recorded their own ECG with no prior training — Has FDA Breakthrough Device Designation, U.S. pivotal study planned for Q1 2027 — Risk: small 132-patient study, sensitivity only around 60%, and not FDA-cleared for heart attack use
02-NOV-2026 08:32 AM ET
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