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Market Authorizations: APPLE ECG App, APPLE Irregular Rhythm Notification Feature, LUMOXITI, PK Papyrus System, AJOVY — Drug and Device Digest

ECG App Apple INDICATION FOR USE: The ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The […]

via Market Authorizations: APPLE ECG App, APPLE Irregular Rhythm Notification Feature, LUMOXITI, PK Papyrus System, AJOVY — Drug and Device Digest

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