Withings’ wearable receives medical CE marking

Withings’ wearable receives medical CE marking

Withings announced the European availability of ScanWatch after receiving the CE marking for medical devices. Developed by cardiologists and sleep experts, it is the world's first clinically validated hybrid smartwatch to detect both atrial fibrillation (AFib) and overnight breathing disturbances.

Withings’ most medically advanced wearable to date, it boasts an exceptional battery life of up to 30 days and is designed to help  users and their physicians monitor overall health through a wearable that identifies highly prevalent, yet largely underdiagnosed cardiovascular, respiratory and sleep breathing issues early.

COVID-19 ResponseThe COVID-19 pandemic has caused the medical community to quickly readjust and refocus on offering telehealth options for connecting with and monitoring patients. In addition to detecting AFib and overnightbreathing disturbances, ScanWatch can also be helpful for those with COVID-19 to monitor their blood oxygen saturation levels on-demand from home via the embedded SpO2 sensor. To assist the medical community during this time, Withings is currently involved in a research initiative with the Department of Cardiology at the university hospital of the Ludwig Maximilians University of Munich, which is integrating ScanWatch into a COVID-19 patient monitoring project. Additionally, to meet the needs of its customers and physicians alike, the Withings team decided to get ScanWatch onto the wrists of consumers as soon as possible with the September release in Europe. Currently, ScanWatch is CE marked for AFib detection, both via electrocardiogram (ECG) and photoplethysmography (PPG). ScanWatch currently can detect overnight breathing disturbances with the full CE clearance for sleep apnea detection capabilities expected later this year.

“We announced ScanWatch earlier this year to an enthusiastic response. Today, itscapabilities to detect heartrhythm disorders as well as totrack blood oxygen saturation levels have become even more amplified due to COVID-19,” said Mathieu Letombe, CEO of Withings. “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 U.S. availability.

In-depth cardiovascular monitoring

”AFib is the mainform of irregular heart rhythm that is often underdiagnosed as it can be intermittent and easily missed if symptoms are not occurring during infrequent doctors’ visit. ScanWatch can detect if a user has AFib thanks to its ability to take a medical-grade ECG on-demand. ScanWatch also enables users to identify if their heart rhythm is slow, high or shows sign of AFib through a proactive heart scanning feature. Through its embedded PPG sensor, the device has the ability tomonitor heart rate, which allows it to alert the user to a potential heart event even if they don’t feel palpitations. When ScanWatch detects an irregular heartbeat through its heart rate sensor, it will prompt the user via the watch display to record an ECG in just 30 seconds.

Withings’ wearable receives medical CE marking

Breathing disturbances detection

One billion people are estimated to suffer from mild to severe sleep apnea, however, 8 out of 10 people don’t know they have it.1 ScanWatch cand etect the presence ofbreathing disturbances during sleep, meaning the user has stopped breathing for several seconds multiple times a night, which can be a sign of sleep apnea. Sleep breathing disturbances are detected by an exclusive algorithm based on an analysis of blood oxygen level, heart rate, movement and breathing frequency, collected through ScanWatch’s accelerometer and the optical sensor.Currently, users can see the intensity of breathing disturbances that occurredduring the night,in the Health Mate app, from low to high. Medical-grade sleep apnea detection will automatically become available following further regulatory approval later this year.In addition, ScanWatch provides sophisticated sleep monitoring and analysis of sleep patterns, including the length, depth and quality of sleep, and can wake users up with a gentle vibration at the best time of their sleep cycle.

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