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HeartBeam has developed a cable-free, credit card-sized device capable of capturing high-fidelity heart electrical signals from three distinct directions and synthesizing them into a standard diagnostic-quality, medical-grade, portable “12-lead” electrocardiogram. The pivotal VALID–ECG study met its clinical endpoints in early/mid–2025. The company received FDA clearance in December 2024 for arrhythmia assessment with its device; an application for broader use was submitted in January 2025. Commercial launch will follow further regulatory clearances. Early access programs are underway to prepare the market and gather feedback from clinicians
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