February 22, 2024

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The US Food and Drug Administration has approved the sleep apnea detection feature in the Samsung Galaxy Watch

The US Food and Drug Administration has approved the sleep apnea detection feature in the Samsung Galaxy Watch

The Samsung Galaxy Watch has a feature that no other smartwatch has today, which is the ability to detect sleep apnea.

Yes Specific property It recently received approval from the US Food and Drug Administration (FDA). Considering how many people today suffer from sleep apnea or other sleep disorders, the Samsung Galaxy Watch has gained a significant advantage over its competitors – however, it requires a Galaxy smartphone to operate.

Today, smartwatches and other wearable devices have proven to be quite capable of monitoring our health. However, in many cases, companies need approval from regulatory bodies before they can begin developing or promoting certain features. In the US, that regulatory body is usually the Food and Drug Administration (FDA), and it recently gave its approval to a feature that represents a big win for Samsung. The well-known Korean company recently announced that it has received De Novo approval from the US Food and Drug Administration for the sleep apnea detection feature found in the Samsung Galaxy Watch sold on the other side of the Atlantic.

This is a major industry first for the Korean company, as no other mass-market smartwatch has this feature, including the Apple Watch, Samsung's main competitor in this market segment. In case you are wondering what De Novo approval is, it is described by the US Food and Drug Administration as follows: “De Novo provides a marketing or promotional means for the classification of advanced medical devices, through which general controls alone or general and specific controls are established.” 'Guaranteed safety and efficacy for intended use, but no other comparator device is legally marketed.'

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In other words, the US Food and Drug Administration has given its approval to Samsung to market the Galaxy Watch's sleep apnea detection feature because its “safety and effectiveness are assured.”

According to SamsungObstructive sleep apnea (OSA) affects up to 25% of men and 10% of women in the United States. Sleep apnea causes a person's breathing to temporarily stop during sleep, which clearly negatively affects the quality of sleep and in some cases may pose a health risk. Sleep apnea is also associated with cardiovascular diseases such as high blood pressure, coronary heart disease, heart failure, arrhythmia, and strokes. Being able to detect them and then deal with them can be very useful to users.

This feature requires a Galaxy Watch paired with a Galaxy smartphone to work (users must be over 22 years old and wear the watch to sleep for at least two four-hour sessions over a ten-day period to receive data on whether there are signs of apnea While sleeping or not is detected). As the Korean company announced, the feature will be available through an update in the third quarter of this year. Unfortunately, Samsung hasn't been clear about which Galaxy Watch models will get this feature, but we're guessing the latest Galaxy Watch 6 and Galaxy Watch 6 Classic will be on the list. However, by the third quarter of this year, the new Galaxy Watch 7 series will be released, so the company may want to combine promotion of the new series with an innovative feature (which will logically reach other models through the update).

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