Withings’ ScanWatch Fibrillation Detector Gets 510(k) Clearance

October 15, 2021

France-based devicemaker Withings has received 510(k) marketing clearance from the FDA for its ScanWatch wearable device.

The FDA clearance covers the detection of atrial fibrillation detection using a medical-grade electrocardiogram and the measurement of blood oxygen levels from the wrist.

The device, which can also aid in the detection of breathing disturbances at night that can be signs of sleep apnea, will be available in North America starting next month, the company said.

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