Withings gets FDA nod for medical smartwatch ScanWatch

"Withings said has received clearance from the Food and Drug Administration (FDA) for its medical-grade ScanWatch, a smartwatch that can detect heart rate problems.

The hybrid smartwatch and medical device can detect atrial fibrillation, a heart rate irregularity also known as “AFib,” through both electrocardiogram (ECG) and measurement of SpO2 levels from the wearer’s wrist. The latter is important in detecting whether someone has severe COVID symptoms.

Issy-les-Moulineaux, France-based Withings is one of the pioneers of connected health, and it can now start selling the device in North American in November. The device, already on sale in Europe and Australia, can make a big difference with its health measurements.

It looks like a classic wristwatch, but the device has sensors that can monitor heart rate, atrial fibrillation through ECG, breathing disturbances, blood oxygen levels through SpO2, sleep, and physical activity.

ScanWatch is the first wearable to simultaneously be cleared by the FDA to record ECG and SpO2 measurements. Priced from $279, it will be available from www.withings.com, Best Buy, and Amazon from early November..." Lire la suite