Withings Wins FDA Clearance for Smartwatch That Can Detect Respiratory Issues

Withings Wins FDA Clearance for Smartwatch That Can Detect Respiratory Issues
Image: Withings

Back at CES 2020, Withings threw down the gauntlet with the ScanWatch, a sleek smartwatch it claimed could take electrocardiograms and monitor for respiratory disorders during sleep. It was incredibly ambitious, but since then, we’ve heard nothing but crickets. Now, after nearly two years, the Food and Drug Administration has finally granted the ScanWatch clearance for both its ECG and blood oxygen features.

This would be the first wearable that’s been cleared for features that use both ECG and SpO2 sensors, even though several smartwatches out there already measure blood oxygen levels. FDA clearance is only necessary for features that claim to detect a medical condition. For example, ECG features that advertise the ability to detect atrial fibrillation require the FDA’s approval, while merely taking SpO2 spot readings wouldn’t. In the ScanWatch’s case, Withings is claiming the smartwatch can help detect breathing disturbances that may be indicative of COPD and sleep apnea.

In its press release, Withings says the ScanWatch does this using an “exclusive algorithm” that measures blood oxygen levels, heart rate, movement, and respiratory rate to detect the “presence of nighttime breathing disturbances.” That, in turn, may be able to help detect whether a person is experiencing a respiratory disorder. According to Withings, the ScanWatch has been validated in two clinical studies and is already being used in German hospitals to help remotely monitor patients for covid-19.

That’s pretty big, considering sleep apnea detection has been one of Fitbit’s goals when it introduced SpO2 sensors with its Ionic smartwatch in 2017. It applied for FDA clearance for a sleep apnea feature last year (around the same time that Withings announced the ScanWatch, actually).

The ScanWatch’s advanced health features are baked inside what looks like a typical hybrid analogue smartwatch. It sports a stainless steel case, sapphire glass screen, and a circular digital display up top. It’s also swimproof up to 5 ATM, can be used to track GPS when tethered to your phone, measures VO2 Max, and can track up to 30 activities. It also has a whopping 30 days of estimated battery life.

Technically speaking, the ScanWatch has been available in Europe and Australia for some time now. It just hasn’t been available stateside due to the FDA clearance process. Withings in general hasn’t had the best luck with the FDA. Its Move ECG smartwatch was introduced back at CES 2019 and eventually went on sale in Europe later that year. However, if you look at its U.S. site, the Move ECG is still unavailable for purchase as of October 2021. It’s odd, given that the Move ECG isn’t doing anything drastically different from other ECG-capable smartwatches like the Apple Watch, Samsung Galaxy Watch 4, and Fitbit Sense.

But now Withings finally has a U.S. launch planned for the ScanWatch. The company says the watch will go on sale in early November on its website, Amazon, and Best Buy. The ScanWatch will be available in two case sizes, 38mm and 42mm, and in two colours, black or white. The ScanWatch starts at A$379 for the 38mm and A$406 for the 42mm.