FDA Approval Archives ~ My Mobile India

Highlights FDA approves sleep apnea detection for Samsung Galaxy Watch. Feature set for a Q3 update in the U.S., following South Korea's approval. Smartwatch technology advances health and wellness monitoring capabilities. Users must wear the watch for two sessions to detect sleep apnea symptoms. The Samsung Galaxy Watch is set to enhance its health monitoring capabilities with a new sleep apnea detection feature, following the recent FDA approval. This advancement positions the Samsung Health Monitor app for a significant update in the third quarter of the current year, promising to make this innovative feature available to users in the United States. Bridging Technology and Wellness Bridging Technology and Wellness Before reaching the U.S. market, this feature received clearance from South Korea's Ministry of Food and Drug Safety last fall, showcasing its potential in utilising wearable technology to identify interruptions in breathing during sleep. These interruptions are often indicators of sleep apnea, a condition characterized by pauses in breathing or periods of shallow breathing during sleep. FDA approves sleep apnea detection for Samsung Galaxy Watch Despite skepticism from the medical community regarding the reliability of smartwatches in diagnosing sleep apnea and other health conditions, this development underscores the tech industry's commitment to expanding the health and wellness capabilities of wearable devices. Tech giants like Apple, Fitbit, and Withings are also exploring the health monitoring space, aiming to integrate sophisticated features that can track sleep quality, including potential signs of sleep apnea and hypertension. Setting New Standards in Health Monitoring Setting New Standards in Health Monitoring Apple's endeavors to incorporate advanced health monitoring features into the next iteration of the Apple Watch, as reported by Bloomberg, highlight the competitive landscape of wearable technology. However, Apple's journey is currently marked by challenges, including an ongoing patent lawsuit related to blood oxygen monitoring technology, which has impacted the availability of this feature in their current product lineup. To leverage the sleep apnea detection functionality on the Samsung Galaxy Watch, users are required to wear the device during sleep for two sessions, each lasting a minimum of four hours, within a span of ten days. Samsung Galaxy Watch to Introduce Sleep Apnea Detection Following FDA Approval This procedure enables the watch to monitor blood oxygen levels overnight, identifying any significant drops indicative of sleep apnea or related sleep disorders. The Mayo Clinic identifies breathing interruptions as a critical symptom of sleep apnea, which can manifest in two forms: central sleep apnea, caused by the brain's failure to signal the muscles responsible for breathing, and obstructive sleep apnea, resulting from physical blockages that prevent air from flowing to the lungs. FAQs Q: What new feature is coming to the Samsung Galaxy Watch? A: The Samsung Galaxy Watch will soon include a sleep apnea detection feature, recently approved by the FDA, enhancing its health monitoring capabilities. Q: When will the sleep apnea detection feature be available in the U.S.? A: Sleep apnea detection is scheduled for release in the third quarter of the current year, as part of an update to the Samsung Health Monitor app for U.S. users. Q: How does the Galaxy Watch detect sleep apnea? A: The feature requires users to wear the watch during sleep for two separate sessions of at least four hours each within ten days, using blood oxygen monitoring to detect potential sleep apnea. Q: What does sleep apnea detection signify for wearable technology? A: This development highlights the growing role of wearable devices in health and wellness, offering users innovative tools to monitor potential health conditions like sleep apnea. Q: Are there other companies working on similar health monitoring features? A: Yes, companies like Apple, Fitbit, and Withings are also exploring health monitoring capabilities in their wearable devices, aiming to track sleep quality and detect signs of sleep apnea and other conditions. Q: Samsung’s Sleep Apnea Feature on Galaxy Watch First of Its Kind Authorized by US FDA. Details? A: Samsung Electronics Co., Ltd. announced that the sleep apnea feature1 on the Samsung Health Monitor app2 has received De Novo authorization from the United States Food and Drug Administration (FDA). This feature, will detect signs of sleep apnea using a compatible Samsung Galaxy Watch and Phone, is the first of its kind to be authorized by FDA following previous approval by South Korea’s Ministry of Food and Drug Safety (MFDS), announced last October in South Korea. The sleep apnea feature will enable users over the age of 22 who have not been diagnosed with sleep apnea to detect signs of moderate to severe obstructive sleep apnea (OSA) over a two-night monitoring period, a common and chronic sleep condition that often goes undiagnosed and untreated. To utilize the feature, users will be able to simply track their sleep twice for more than four hours within a ten-day period. OSA causes a person to stop breathing while sleeping and can often result in disruptions in oxygen supply, lower sleep quality and daytime fatigue. Untreated sleep apnea can compound the risk of cardiovascular diseases such as hypertension, coronary artery disease, heart failure, cardiac arrhythmias and stroke. According to the National Sleep Foundation (NSF), roughly 25% of men and 10% of women in the U.S. experience OSA. The new feature on the Samsung Health Monitor app is expected to help more people proactively detect moderate or severe forms of OSA, and as a result of the detection seek medical care to reduce the possibility of health-related complications. Good health is strongly linked to good sleep. Sleep helps our bodies and minds recover and empowers us to wake up refreshed and ready for the day ahead. The quality of sleep we get every night has a significant impact on our physical and mental well-being, our relationships, our performance and much more. Samsung recognizes the foundational role that sleep serves in our health and well-being by focusing on three key elements for better sleep: understanding sleep patterns, building better habits and creating a sleep-friendly environment. With the sleep apnea feature, Samsung is taking the next step in its ongoing commitment to provide Galaxy users with the best possible sleep tools to improve their sleep health habits. The feature will be available on the Galaxy Watch series in the US via Samsung Health Monitor app in the third quarter. Also Read: Apple Watch Set to Reportedly Reinvent Health Tech with New Blood Pressure, Sleep Apnea Monitoring Features Also Read: Samsung Galaxy Watch 6 Classic 5K Leaked Renders Show Rotating Bezel Comeback, Reveal Full Design; Launch Soon

FDA Approval

Samsung Galaxy Watch to Introduce Sleep Apnea Detection Following FDA Approval

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