Samsung’s Galaxy Watch Gets FDA Approval for Sleep Apnea Feature

Is anyone suffering from sleep apnea? 🤔 While not all individuals who snore also have sleep apnea, the two conditions are frequently associated with each other. 

Samsung announced that the sleep apnea detection feature in the Samsung Health Monitor app has received “De Novo” approval from the US FDA.

The sleep apnea feature is centered on detecting signs of sleep apnea using the Samsung Galaxy Watch and mobile phone, and detecting symptoms at an early stage. With this approval, Samsung is expected to release a Galaxy Watch with ‘sleep apnea detection’ within the year. It will be seven years since the company first launched the Galaxy Watch in 2018, and the first device to receive FDA approval. This is also the first time the FDA has approved a software medical device for a wearable device.

Samsung has been pushing hard for the FDA approval, citing ‘digital healthcare’ as a way to overturn the smartphone and wearable market, where it is losing ground to Apple. In fact, Apple temporarily halted sales of the Apple Watch Series 9 and Apple Watch Ultra 2 after losing a patent dispute with Masimo for including a ‘blood oxygen monitoring’ feature in the Apple Watch.

With this approval, Samsung hopes to enter bright future with ‘digital health’.

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