Samsung Electronics has announced that the brainwave analysis feature on the Samsung Health Monitor app has received De Novo clearance from the U.S. Food and Drug Administration (FDA). This innovative add-on, which utilizes the compatible Galaxy Watch and Samsung phone, allows for the detection of symptoms of obstructive sleep apnea. It is the first of its kind to receive FDA clearance, following earlier approval from the South Korean Ministry of Food and Drug Safety (MFDS) in October of last year.
The sleep study feature on the Galaxy Watch enables the detection of moderate and severe obstructive sleep apnea (OSA) symptoms in users above the age of 22 who have not yet been diagnosed with the condition. This often undiagnosed and untreated condition causes a person to stop breathing during sleep, leading to interruptions in oxygen supply, worsened sleep quality, and increased daytime fatigue. Untreated sleep apnea can increase the risk of cardiovascular diseases such as hypertension, ischemic heart disease, heart failure, cardiac arrhythmia, and stroke. According to the National Sleep Foundation (NSF), about 25% of men and 10% of women in the United States suffer from obstructive sleep apnea. The new feature in the Samsung Health Monitor app aims to actively detect moderate and severe cases of OSA, thereby encouraging users to seek medical help in order to reduce health-related complications.
Quality sleep has a significant impact on overall human health. Sleep helps the body and mind regenerate, making a person wake up refreshed and ready for the day ahead. The quality of sleep an individual receives each night has a significant influence on their physical and mental well-being, relationships, productivity, and much more. Samsung recognizes the fundamental role that sleep plays in the health and well-being of people, which is why they focus on three key elements that help improve sleep: analyzing sleep patterns, building better habits, and creating a conducive sleeping environment.
With the brainwave analysis feature, Samsung takes another step in its endeavor to provide Galaxy users with the best tools for improving sleep health. This feature will be available on the Galaxy Watch series in the United States through the Samsung Health Monitor app in the third quarter.
FAQ section based on the main topics and information presented in the article:
1. What feature did Samsung Electronics announce?
Samsung Electronics announced that the brainwave analysis feature on the Samsung Health Monitor app has received De Novo clearance from the U.S. Food and Drug Administration (FDA).
2. What benefits does the Galaxy Watch sleep study feature bring?
The sleep study feature on the Galaxy Watch enables the detection of symptoms of obstructive sleep apnea (OSA) in users above the age of 22 who have not yet been diagnosed with the condition. It helps detect moderate and severe cases of OSA, which are often undiagnosed and untreated, leading to health complications.
3. What are the consequences of untreated sleep apnea?
Untreated sleep apnea can increase the risk of cardiovascular diseases such as hypertension, ischemic heart disease, heart failure, cardiac arrhythmia, and stroke.
4. What are the statistics regarding sleep apnea in the USA?
According to the National Sleep Foundation (NSF), about 25% of men and 10% of women in the USA suffer from obstructive sleep apnea.
5. What are the three key elements Samsung focuses on to improve sleep?
Samsung focuses on analyzing sleep patterns, building better habits, and creating a conducive sleeping environment to improve sleep.
6. When will the brainwave analysis sleep study feature be available on the Galaxy Watch in the USA?
The brainwave analysis sleep study feature will be available on the Galaxy Watch series in the USA through the Samsung Health Monitor app in the third quarter.
Dictionary:
1. Obstructive Sleep Apnea (OSA) – a condition that causes a person to stop breathing during sleep, leading to interruptions in oxygen supply, worsened sleep quality, and increased daytime fatigue.
2. De Novo – a clearance granted by the U.S. Food and Drug Administration (FDA) for the introduction of a new diagnostic or therapeutic method that is not assigned to any existing classification.
Suggested Related Links:
– Link to Samsung Health app
– Link to Galaxy Watch website
The source of the article is from the blog krama.net