Withings’ ScanWatch now has the formal approval of the US Food and Drug Administration (FDA). The certification covers the ScanWatch’s electrocardiogram (ECG) and blood oxygen detection (SpO2) capabilities, and clears the watch for use in medical applications.
In that regard, the ScanWatch is expected to serve as a diagnostic tool. The ECG is a heart rate monitor that can detect cardiac conditions like atrial fibrillation (AFib), while the SpO2 sensor can help track respiratory problems like sleep apnea and COVID-19. In those cases, lower blood oxygen levels serve as an indicator of a more serious breathing issue.
The ScanWatch has already been used in two clinical trials, including a German study in which doctors used it to monitor patients’ COVID-19 symptoms remotely. The watch also has fitness and sleep trackers that go beyond its utility as a medical device. For example, the watch can track steps, calories, and different kinds of workout routines, and comes with a VO2 Max indicator that gauges how well the wearer converts oxygen into physical output while exercising. The result serves as an estimate of someone’s overall fitness level.
All of the data gathered with the ScanWatch can be viewed in the free Health Mate companion app. Wearers can then choose to send that data to their doctor should they wish to do so. The watch itself is water-resistant to a depth of five meters.
The ScanWatch originally debuted at CES 2020, where it received three CES Innovation Awards. The watch is already available in Europe and Australia, but the FDA certification clears the way for a launch in the United States. Withings has indicated that the device will enter the US market in November.
“We are now thrilled to bring it to the United States following robust FDA scrutiny,” said Withings CEO Mathieu Letombe. “Our mission is to create devices people use and wear every day so the medical data they provide can make meaningful impacts on their lives. ScanWatch is our most ambitious medical watch to date and has the potential to benefit millions of people.”
The Withings ScanWatch will retail for $279, though there is a 42 mm version available for $300. Heart rate and blood oxygen detection have become increasingly common in the latest generation of smartwatches, though the ScanWatch is the first wearable with both ECG and SpO2 certification from the FDA.