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Withings Wins FDA Clearance for Smartwatch That Can Detect Respiratory Issues




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 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 introduced a SpO2 feature last year (around the same time that Withings announced the ScanWatch, actually), but a Fitbit spokesperson told Gizmodo that the company “continues to collect clinical data to test and develop an FDA cleared feature for sleep apnea, which we expect to submit for FDA clearance.”