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Withings Announces the FDA Clearance of ScanWatch -- Its Most Advanced Hybrid Smartwatch

ScanWatch receives FDA clearance for atrial fibrillation detection using ECG*, and measuring SpO2 levels from the wrist.


News provided by

Withings

Oct 12, 2021, 09:02 ET

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ISSY-LES-MOULINEAUX, France, Oct. 12, 2021 /PRNewswire/ -- Today, Withings, pioneers of the connected health revolution, is pleased to announce ScanWatch has received FDA clearance.

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Withings ScanWatch
Withings ScanWatch

Using state-of-the-art technology, ScanWatch can help detect atrial fibrillation through ECG and blood oxygen levels through SpO2, as well as perform general wellness functions like monitoring sleep quality, and physical activity, and checking heart rate.  ScanWatch has already been adopted by countless users around the world since its launch in Europe and Australia and will now be available in the United States beginning of November 2021.

ScanWatch has been FDA cleared to both record ECG & SpO2 measurements. Priced from $279, it will be available from  www.withings.com, Best Buy, and Amazon from early November.

“ScanWatch received three CES Innovation Awards when it was announced and we are now thrilled to bring it to the United States following FDA clearance” said Mathieu Letombe, CEO of Withings. “At Withings our core mission is to create beautiful devices people choose to use and wear every day so the medical data they provide can make meaningful impacts on their lives. ScanWatch has been clinically validated to detect AFib. It is our most ambitious watch to date and has the potential to help millions of people track medical and wellness data.”  
 
Developed with cardiologists and other medical experts, ScanWatch has been validated in clinical studies. It has been available in Europe where it has also been used in a study to monitor patients remotely in German hospitals. It is designed with a stainless-steel case and durable sapphire glass watch face and features a large digital display as well as easy navigation through a newly created crown dial. Additionally, ScanWatch is water-resistant up to 5 ATM and features an exceptional battery life of up to 30 days. 

Cardiovascular Health Monitoring
AFib is the main form of irregular heart rhythm. It can be intermittent and not detected during doctors’ visits. ScanWatch helps to detect if a user is experiencing an Afib episode thanks to its ability to take an ECG on-demand. The device also can monitor heart rate. ECG readings are displayed in the accompanying Withings Health Mate app where users can choose to send readings to their doctor or cardiologist.  

Blood oxygen level via SpO2 and Sleep tracking
With FDA Clearance of its SpO2 functionality, ScanWatch can be used to track blood oxygen levels and can be used to track breathing disturbances. ScanWatch has an exclusive algorithm that analyzes blood oxygen levels, heart rate, movement, and respiratory rate, all collected via the accelerometer and optical sensors.

In addition, ScanWatch provides sophisticated sleep tracking 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, in order to help patients with sleep management.     

Activity & Workout Tracking
ScanWatch is a sophisticated activity monitor able to track parameters such as steps, calories, elevation, workout routes (via connected GPS) and can automatically recognize more than 30 daily activities such as walking, running, swimming, and cycling. In addition, it offers Fitness Level assessments through estimation of an indicator called VO2 Max, which measures the heart and muscle's ability to convert oxygen into energy during physical exercise.

Like all Withings devices, ScanWatch connects with the free Health Mate app, which provides data and insights and can schedule activity reminders, set goals, and manage wellness achievements. In addition, Health Mate can be paired with more than 100 third-party apps, including Apple Health, Google Fit, Strava, and MyFitnessPal.

Availability
ScanWatch will be available early November, 2021 from withings.com, Amazon and Best Buy stores.  It is priced at $279 (38mm) and $299 (42 mm) and comes in a choice of black or white faces. Customers are encouraged to visit the ScanWatch page on withings.com for early availability news.

*US users only : ECG requires a free in-app activation process, which ensures it is used under the care of a physician. ECG is not intended for use by people under 22 years old.

About Withings  
Established in 2008, Withings, is a world leader in connected health technology. Its team of engineers, data scientists, and healthcare professionals have enthused everyday, elegant lifestyle objects with medical and wellness capabilities to efficiently track health vitals. Its range of in-home devices can monitor more than 20 health parameters and are used daily by millions of people worldwide. Its portfolio of devices includes connected scales, hybrid watches, smart thermometers, blood pressure monitors, and sleep trackers to empower individuals to take back control of their health and track medical and wellness data.

Withings UK & North American Media Contacts:                                      
Ian Twinn [email protected]  

SOURCE Withings

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