Withings ScanWatch Receives CE Certification For Medical Devices

Withings ScanWatch CE certification
Image: Withings

Withings announced that its ScanWatch has received CE marking for medical devices. It means the smartwatch can be sold in Europe. The watch is now available in Europe for 279€.

Unveiled at the CES 2020, the smartwatch can take ECG, detect sleep apnea and boasts an estimated 12 months of battery life. According to Withings, the ScanWatch is the world’s first clinically validated hybrid smartwatch to detect atrial fibrillation (AFib), blood oxygen levels (SpO2), and sleep apnea.

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The ScanWatch is still awaiting FDA approval for sale in the US, but hopefully it will be available worldwide soon.

The ScanWatch comes with a PPG sensor, which continuously monitors the wearer’s heart rate and alert them if there’s an irregular heartbeat or arrhythmia. If an arrhythmia is detected the watch prompts the user to take an ECG reading. The user can see the ECG results either on their watch screen or in the watch’s Health Mate app. Afterwards, they can print out a graph of their ECG to send to their doctor.

Sleep apnea is a serious sleep disorder that occurs when a person’s breathing is interrupted during sleep. People with this condition stop breathing repeatedly during their sleep, sometimes hundreds of times. Due to this, the brain and the rest of the body are deprived of enough oxygen. However, eight out of 10 people with this condition aren’t aware that they have, Withings said in the press material.

Mobile phones displaying health apps
Image: Withings

The SpO2 feature in the watch can measure oxygen saturation continuously and let you know if you’re experiencing any sleep apnea episodes. And like other sleep trackers, the ScanWatch will provide detailed sleep analysis like duration, depth regularity, and interruptions.

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“We announced ScanWatch earlier this year to an enthusiastic response. Today, its capabilities to detect heart rhythm disorders as well as to track blood oxygen saturation levels have become even more amplified due to COVID-19,” said Mathieu Letombe, CEO of Withings, reports MobiHealthNews.

“With the CE mark regulatory approval for AFib detection and SpO2 measurement, we are delighted to be able to make ScanWatch available to customers in Europe now, with medical-grade sleep apnea detection coming later this year as well as US availability.”

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Sam Draper () is Online Editor at WT | Wearable Technologies specialized in the field of sports and fitness but also passionated about any new lifestyle gadget on the market. Sam can be contacted at press(at)wearable-technologies.com.