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Home » FDA clearance adds glow to Heartbeam prospects
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FDA clearance adds glow to Heartbeam prospects

Dec. 16, 2024
By Annette Boyle
Heartbeam Inc. received U.S. FDA 510(K) clearance for its portable, non-invasive electrocardiogram system that enables on-the-go recording of heart signals. The cable-free, credit card-sized device uses five electrodes to capture signals from three directions and can be used whenever a patient feels symptoms, overcoming the challenge of identifying intermittent arrhythmias, which are often not experienced during scheduled appointments, without requiring patients to wear a device continuously.
BioWorld MedTech Regulatory Artificial intelligence Cardiovascular U.S. FDA

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