The Food and Drug Administration on Tuesday approved a new smartwatch that includes a blood oxygen monitor and an EKG sensor to track a wearer’s vital signs, the first device to receive simultaneous approval.
Created by healthcare technology company Withings, the ScanWatch can record ECG and SpO2 measurements, detect sleep irregularities, and document physical activity.
“[ScanWatch] it is our most ambitious medical watch to date and has the potential to benefit millions of people, “said Mathieu Letombe, Withings CEO, in a press release.
Healthcare organizations are increasingly interested in adopting wearable technology for use in remote patient monitoring and condition care management, an area of focus accelerated by the COVID-19 pandemic.
In 2020, the FDA created the Center of Excellence for Digital Health 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 various Apple watches, Samsung Galaxy watches, and Fitbit Sense.
While some of these watches and others from Garmin and Amazon have the technology to monitor blood oxygen levels, the Fitbit Versa 3 is the only other device besides ScanWatch approved by the FDA for its pulse oximeter.
Some healthcare systems are testing the integration of these products to determine if the data they provide is as accurate as traditional medical devices and if the devices will widen health disparities due to cost.
Apple plans to study whether its Apple Watch Series 6 technology can actually detect early signs of respiratory conditions like COVID-19 or influenza. For now, the company said that the blood oxygen sensor is only intended to provide users with information about their general well-being.
The ScanWatch has been tested through clinical trials to detect atrial fibrillation and signs of respiratory problems such as 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.
Starting in November, ScanWatch will be available to North American consumers at multiple sites.
Despite the fact that some wearable technologies have obtained FDA approval, there are still questions about the precision and effectiveness of consumer health devices as tools to track vital signs such as blood pressure and oxygen saturation.
Monitoring blood oxygen levels with a smart watch. reflective mode It has been shown to be inferior to the mode of transmission used by fingertip pulse oximeters used by clinical workers, according to a 2016 study from the National Research Foundation of Korea.
Even more reliable pulse oximeters have precision issues, as black patients are three times more likely than white patients to have the devices lose their low oxygen levels.
2021 University of Michigan School of Medicine Study, which appeared in the New England Journal of Medicine, found that this could result in inaccurate readings among up to one in 10 black patients.
Given the need for pulse oximetry to make medical decisions, particularly during the pandemic, the select findings of inaccuracy mean that not all consumers and healthcare professionals are ready to approve of smartwatch technology just yet.