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Medical Devices / Submissions and Approvals

Biofourmis’ ECG Monitor Cleared by FDA for Sensing Cardiac Arrhythmias

May 6, 2019
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The FDA granted 510(k) clearance for Biofourmis’ RhythmAnalytics, an ECG monitoring device for detecting heart arrhythmias.

The monitor automatically analyzes heart arrhythmias and can detect 15 different types, including ventricular arrhythmias, ventricular ectopic beats and atrial fibrillation.

The device uses artificial intelligence models formed using over a million ECG recordings from multiple wearable monitors approved by the FDA.

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