Samsung has announced that its unique sleep apnea detection feature on the Galaxy Watch has received approval from the US Food and Drug Administration (FDA). The sleep apnea feature, part of the Samsung Health Monitor application, was approved by the FDA through De Novo authorization. This makes it the first FDA-approved feature of its kind, following a previous approval by the Korean Ministry of Food and Drug Safety (MFDS) in October of last year.
The new feature will allow users above the age of 22, who have not been diagnosed with sleep apnea, to detect signs of moderate or severe obstructive sleep apnea (OSA) during two nights of monitoring, according to the company. Sleep apnea is a common, chronic sleep disorder that often goes undiagnosed and untreated. To utilize this feature, users must track their sleep for at least four hours on two separate occasions within a ten-day period.
Sleep apnea is a medical condition characterized by brief pauses in normal breathing during sleep. There are various forms of sleep apnea, including “central sleep apnea,” in which the brain fails to send sufficient signals to control breathing during sleep, and “obstructive sleep apnea,” in which relaxed muscles hinder the airflow to the lungs.
OSA causes a person to stop breathing during sleep, often leading to oxygen deprivation, degraded sleep quality, and increased daytime fatigue. Untreated sleep apnea can increase the risk of cardiovascular diseases such as hypertension, coronary artery disease, heart failure, cardiac arrhythmias, and strokes.
According to the National Sleep Foundation (NSF), approximately 25% of men and 10% of women in the United States suffer from OSA, as stated by the company in their announcement.
The new Samsung Health Monitor application feature is designed to help more individuals detect moderate or severe forms of OSA and encourage them to seek medical care to reduce the risk of health complications.
FAQ:
1. What feature did Samsung introduce on its Galaxy Watch smartwatch?
Samsung introduced a sleep apnea detection feature on its Galaxy Watch smartwatch.
2. Which regulatory agencies have approved this feature?
The sleep apnea feature within the Samsung Health Monitor application has been approved by the US Food and Drug Administration (FDA) and the Korean Ministry of Food and Drug Safety (MFDS).
3. How does the sleep apnea detection feature on the Galaxy Watch work?
The feature enables the detection of sleep apnea using a compatible model of the Galaxy Watch and a smartphone, making it the first FDA-approved feature of its kind.
4. Who can benefit from this feature?
Users above the age of 22, who have not been diagnosed with sleep apnea, can benefit from this feature.
5. How long does the monitoring of sleep apnea signs take?
Users must track their sleep for at least four hours on two separate occasions within a ten-day period.
Definitions:
– Sleep apnea: A medical condition characterized by brief pauses in normal breathing during sleep.
– Obstructive sleep apnea (OSA): A form of sleep apnea in which relaxed muscles hinder the airflow to the lungs.
– Galaxy Watch: A smartwatch created by Samsung.
Useful links:
– Official Samsung website
– US Food and Drug Administration (FDA) website
The source of the article is from the blog papodemusica.com