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Medical Devices / Submissions and Approvals

FDA Clears AliveCor’s Electrocardiogram Device

April 24, 2019
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AliveCor received 510(k) clearances for two new indications for its KardiaMobile electrocardiogram device that now detects the three most common forms of heart arrythmia.

The newly cleared indications are for slow heartbeat (bradycardia) and fast heartbeat (tachycardia). The product was previously cleared for detecting atrial fibrillation (AFib).

The device, which works with most smartphones, can now inform physicians and patients about non-AFib arrhythmias that indicate bradycardia or tachycardia.

The ECG monitor can also share its rhythm results via the Apple Watch, allowing for the preemptive detection and treatment of AFib.

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