Samsung Electronics introduced that the sleep apnea function on the Samsung Well being Monitor app has obtained De Novo authorization from the US Meals and Drug Administration (FDA).
This over-the-counter function, which detects indicators of sleep apnea utilizing a suitable Samsung Galaxy Watch and cellphone, was the primary of its variety to be licensed by the FDA following earlier approval by Korea’s Ministry of Meals and Drug Security in Korea, introduced final October.
The sleep apnea function permits customers over age 22 who haven’t been identified with sleep apnea to detect indicators of reasonable to extreme obstructive sleep apnea (OSA) over a two-night monitoring interval. To make the most of the function, customers can monitor their sleep twice for greater than 4 hours inside a 10-day interval.
The function on the Samsung Well being Monitor app is anticipated to assist extra individuals proactively detect reasonable or extreme types of OSA, and, because of the detection, search medical care to cut back the potential for health-related issues, in line with a launch from Samsung.
“With the sleep apnea function, Samsung is taking the subsequent step in its ongoing dedication to offer Galaxy customers with the very best sleep instruments to enhance their sleep well being habits,” says the corporate within the launch.
The software-only function is just not supposed for customers who’ve beforehand been identified with sleep apnea. Customers shouldn’t use this function to exchange conventional strategies of analysis and therapy by a professional clinician. The info offered by this system can be not supposed to help clinicians in diagnosing sleep problems.
The function will likely be accessible on the Galaxy Watch sequence within the US through the Samsung Well being Monitor app within the third quarter.
Picture caption: Galaxy Watch
Picture credit score: Samsung Electronics