The Food and Drug Administration on Tuesday signed off on a new smartwatch that includes a blood oxygen monitor and electrocardiogram sensor to track the wearer's vitals, the first device to receive simultaneous approval.
Created by the health technology company Withings, the ScanWatch can record ECG and SpO2 measurements, detect sleeping irregularities and document physical activity.
"[ScanWatch] is our most ambitious medical watch to date and has the potential to benefit millions of people," said Mathieu Letombe, CEO of Withings, in a news release.
Healthcare organizations are becoming increasingly interested in adopting wearable technology to use for remote patient monitoring and condition care management, a focus area accelerated by the COVID-19 pandemic.
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In 2020, the FDA created the Digital Health Center of Excellence to support and coordinate the regulation of digital health technologies categorized as medical devices.
There are already numerous smartwatches for sale with FDA-approved ECG sensors, including several Apple Watches, Samsung Galaxy Watches and the Fitbit Sense.
While some of these watches and others from Garmin and Amazon have the technology to monitor blood oxygen levels, Fitbit Versa 3 is the only other device aside from ScanWatch to FDA approvel for its pulse oximeter.
Some health systems are testing out the integration of these products to determine if the data they provide is as accurate as traditional medical devices, and whether the devices will widen health disparities due to costs.
Apple plans to study whether its Apple Watch Series 6 technology can actually detect early signs of respiratory conditions such as COVID-19 or influenza. For now, the company said the blood oxygen sensor is only meant to provide wearers with insight into their general wellness.
The ScanWatch has been proven through clinical trials to detect atrial fibrillation and signs of respiratory issues like chronic obstructive pulmonary disease and sleep apnea, Withings said in a news release.
Since its launch in Europe and Australia, the watch has also been used in a study to remotely monitor COVID-19 patients in German hospitals.
Beginning in November, ScanWatch will be available to North American consumers on various sites.
Despite some wearable tech gaining FDA approval, there are still doubts about the accuracy and effectiveness of consumer health devices as tools to track vitals like blood pressure and oxygen saturation.
Monitoring blood oxygen levels with a smartwatch's reflective mode has been shown to be inferior to the transmission mode used by fingertip pulse oximeters used by clinical workers, according to a 2016 study by the National Research Foundation of Korea.
Even more reliable pulse oximeters have accuracy issues, as Black patients are three times more likely than white patients to have their low oxygen levels missed by the devices.
The 2021 University of Michigan Medical School study, which appeared in the New England Journal of Medicine, found that this could translate to inaccurate readings among up to one in 10 Black patients.
Given the necessity of pulse oximetry for making medical decisions—particularly during the pandemic—select findings of inaccuracy mean that not all consumers and healthcare professionals are ready to sign off on the smartwatch technology just yet.