Our modern smartwatches and wearable devices have revolutionized the way we track and monitor our health. However, before certain features can be made available to consumers, regulatory bodies such as the Food and Drug Administration (FDA) need to grant their approval. Today, Samsung has achieved a significant milestone in this regard.
Samsung has recently obtained De Novo authorization from the FDA for a groundbreaking sleep apnea detection feature on their Galaxy Watch. This achievement makes the Galaxy Watch the first consumer smartwatch in the industry to have the ability to detect sleep apnea. Notably, even Samsung’s main competitor, the Apple Watch, does not possess this capability.
According to the FDA, De Novo authorization allows for the marketing and classification of innovative medical devices when general controls or a combination of general and special controls provide reasonable assurance of safety and effectiveness. As a result, the FDA has granted Samsung permission to market the Galaxy Watch as a sleep apnea detection device due to its proven safety and effectiveness.
Sleep apnea, specifically obstructive sleep apnea (OSA), affects a significant portion of the adult population in the United States. OSA causes temporary pauses in breathing during sleep, resulting in poor sleep quality and potential health risks. It has been linked to various cardiovascular conditions, including hypertension, coronary artery disease, heart failure, cardiac arrhythmias, and stroke. Detecting and treating sleep apnea can greatly improve an individual’s overall well-being.
To utilize the sleep apnea detection feature, users will need to own a Galaxy Watch paired with a Galaxy smartphone. Samsung plans to roll out this feature in the third quarter of this year. Although Samsung has not specified which Galaxy Watch models will support the feature, it is possible that testing has been conducted on their latest models, such as the Galaxy Watch 6 and Watch 6 Classic. However, as speculation arises, it is important to note that the feature may be exclusive to upcoming models, like the highly anticipated Galaxy Watch 7.
Samsung has also provided some insight into how the sleep apnea detection feature will operate. Users must be aged 22 or above and wear their Galaxy Watch to bed for at least four hours during two separate sleep sessions within a ten-day period. By gathering data during these sleep sessions, the Galaxy Watch can determine if any signs of OSA are present.
The FDA’s approval signifies a significant leap forward for Samsung and the smartwatch industry as a whole. With the introduction of the sleep apnea detection feature on the Galaxy Watch, users can now monitor their sleep patterns and potentially detect and address sleep apnea, thereby improving their overall health and well-being.
Important Terms:
– De Novo: A method of obtaining FDA clearance for marketing and classification of innovative medical devices.
– Sleep Apnea: A condition that causes temporary pauses in breathing during sleep.
Related Links:
– samsung.com: Samsung’s official website
– fda.gov: Food and Drug Administration (FDA) official website
The source of the article is from the blog scimag.news