FDA clears cloud-connected wearable arrhythmia monitor

A wearable device that continuously monitors a patient's ECG to detect cardiac arrhythmias and automatically relay that information to physicians has received FDA approval, St. Paul, Minn.-based VivaQuant announced.

The RX-1 device tracks patients' ECGs throughout their regular daily routines and, when an arrhythmia is detected, uses its built-in cellular connection to transfer that information to the cloud. Staff in a monitoring center then review the report and pass on any clinically significant data to the patients' respective physicians.

The device, which is the size of a smartphone, uses wavelet-based analytics and machine learning to identify atrial fibrillation, atrial flutter, premature ventricular contractions, bradycardia, tachycardia and pauses. The RX-1 is also capable of eliminating up to 95 percent of extraneous electrical noise from ECGs, which can cause false positives, missed cardiac events and other errors.

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