Withings announces ScanWatch has received medical CE marking
French digital firm Withings today announced that its latest wearable is available in Europe, after receiving the CE marking for medical devices.
Developed by cardiologists and sleep experts, Withings says that ScanWatch is the world's first clinically validated hybrid smartwatch to detect both atrial fibrillation (AFib) and overnight breathing disturbances.
The smart watch is designed to help users and their physicians monitor overall health through identifying prevalent, yet largely underdiagnosed cardiovascular, respiratory and sleep breathing issues early.
ScanWatch is CE marked for AFib detection, both via electrocardiogram (ECG) and photoplethysmography (PPG), and for SpO2 measurement. It can also detect overnight breathing disturbances, with the full CE clearance for sleep apnea detection capabilities expected later this year.
WHY IT MATTERS
AFib is the main form 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.
As well as taking a medical-grade ECG on-demand, ScanWatch enables users to identify if their heart rhythm is slow, high or shows sign of AFib through a proactive heart scanning feature.
In addition to detecting AFib and overnight breathing disturbances, ScanWatch can also be helpful for those with COVID19 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.
THE LARGER CONTEXT
Meanwhile, Amazon has entered the wearable health market last month with its on-wrist health tracker and app, Amazon Halo, which measures five health metrics.
Fitbit also recently unveiled a range of new products, including its first ‘advanced health’ smartwatch with ECG capabilities, skin temperature sensor and hear rate tracker
ON THE RECORD
Mathieu Letombe, CEO of Withings: “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.
“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.”