Dive Brief:
- Samsung Electronics has received de novo authorization for a smartwatch and associated mobile app that can detect signs of sleep apnea.
- The Food and Drug Administration authorized the Samsung Galaxy Watch for the detection of signs of moderate to severe obstructive sleep apnea (OSA) in people aged 22 years and older.
- The new feature gives Samsung an edge over competitor Apple, who also sought to add a sleep apnea feature to its smartwatch, according to a report from Bloomberg.
Dive Insight:
Samsung’s smartwatch is an alternative to Apple Watch for people with smartphones that use Google’s Android operating system. For a long time, Apple Watch had more health features, with its users gaining the ability to receive irregular heart rhythm notifications five years before buyers of the Samsung device. Samsung added irregular heart rhythm capabilities after receiving 510(k) clearance last year.
Now, Samsung has gained an advantage over its rival. In November, Bloomberg reported that Apple plans to add the ability to detect sleep apnea to its smartwatch this year. Samsung moved first, with the FDA granting de novo authorization on Feb. 6, following an eight-month review.
The authorization, which comes four months after approval in Korea, covers a feature designed to detect significant breathing disruptions over a two-night monitoring period. Samsung’s authorization supports “on demand use” of the feature in users who have not previously been diagnosed with sleep apnea.
The device is not intended to replace traditional methods of diagnosis or help clinicians diagnose OSA.
Consumer devices that detect signs of sleep apnea could lead to more people being diagnosed. A 2019, Resmed-funded paper found almost 1 billion people have OSA globally, leading editors at The Lancet Respiratory Medicine to warn that the condition may be “both underdiagnosed and under-recognized.”
The FDA de novo authorization makes the Samsung feature a class II product under the generic name “over-the-counter device to assess risk of sleep apnea.” Other companies can now bring similar devices to market by showing substantial equivalence to the Samsung product and complying with the special controls created as part of the de novo authorization.