Withings ScanWatch receives FDA clearance for health features

Withings ScanWatch 2021

Withings announced today that it had received FDA clearance for its latest ScanWatch and shipping the new smartwatch by November this year.

The ScanWatch, Withings hybrid smartwatch continuously scans vital parameters to detect heart health conditions and help improve fitness. Much like the Apple Watch, the ScanWatch can detect atrial fibrillation and makes it easy for users to take an ECG from their wrist.Withings Scanwatch FDA approval

ScanWatch can help users track episodes of breathing disturbances during sleep. The watch monitors oxygen saturation, heart rate, breathing frequency, and movement all night long and uses algorithms to measure indicators for Sleep Apnea.

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What FDA clearance offers for the ScanWatch Withings FDA cleared ScanWatchToday’s announcement showcases Withing’s FDA clearance for atrial fibrillation detection through its medical-grade ECG. The ScanWatch also monitors heart rate, breathing disturbances, blood oxygen levels through SpO2, sleep, and physical activity.

It’s a first-ever for Withings, with the ScanWatch becoming the first wearable to simultaneously be cleared to record ECG & SpO2 measurements. Withings sensor for sleep apnea

Additionally, the ScanWatch has been clinically validated to detect AFib and help detect breathing disturbances when sleeping–which are often symptoms and signs of sleep apnea. 

ScanWatch detects these nighttime breathing disturbances using an exclusive algorithm that looks at blood oxygen levels, heart rate, movement, and respiratory rate that the ScanWatch’s accelerometer and optical sensors collect during sleep.

At this time, sleep apnea has not been FDA cleared. If cleared, the Withings ScanWatch would become the first hybrid smartwatch to offer such a feature.

Withings looks towards health and wellness on your wrist Withings Scanwatch sleep monitoring

In looking at the FDA listings for the company for 2021, they have also received approval for blood pressure measurement systems.

The addition of a blood pressure monitoring function to the ScanWatch would be a game-changer as the only smartwatch that supports it today is the Samsung Galaxy watch using the concept of pulse wave velocity.

If we could think of one change that the company could have introduced, it would be the GPS module. Currently, the ScanWatch uses a ‘Connected GPS,’ meaning it leverages your smartphone’s GPS to map out running routes and distance metrics. By embedding a GPS module into the smartwatch, Withings could have won over more hearts and minds.

The ScanWatch offers impressive battery life

Withings Scanwatch announced

The ScanWatch provides unparalleled battery performance. It can provide up to 30 days of battery life between charges. (with some caveats, of course!). Features such as the Respiratory scan, Quicklook, and always on display during a workout can consume more battery power. The ScanWatch recharges to 80% in about an hour and to 100% in about two hours.

Cost and availability of the ScanWatch in the US

Withing’s ScanWatch starts at $279. It will be available directly from Withings, Best Buy, and Amazon in early November.

The watch features a stainless-steel case and uses durable sapphire glass with a choice of black or white watch faces. Outside of the health features, the ScanWatch offers an outstanding battery life of up to 30 days!

If you are planning to get a smartwatch for the Holidays, you may want to sit tight until November and consider the ScanWatch.

This is especially true if you use other Withings products in your households, such as the Withings Scale or the Blood Pressure monitors.

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Sudz Niel Kar
I am a technologist with years of experience with Apple and wearOS products, have a BS in Computer Science and an MBA specializing in emerging tech, and owned the popular site AppleToolBox. In my day job, I advise Fortune 500 companies with their digital transformation strategies and also consult with numerous digital health startups in an advisory capacity. I'm VERY interested in exploring the digital health and fitness-tech evolution and keeping a close eye on patents, FDA approvals, strategic partnerships, and developments happening in the wearables and digital health sector. When I'm not writing or presenting, I run with my Apple Watch Ultra or Samsung Galaxy Watch and closely monitor my HRV and other recovery metrics.


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