Samsung Galaxy Watch sleep apnea feature receives FDA authorization (2024)

FAQs

Samsung Galaxy Watch sleep apnea feature receives FDA authorization? ›

Samsung Galaxy Watch sleep apnea feature receives FDA authorization. On Feb. 9, 2024, Samsung Electronics announced the sleep apnea feature on the Samsung Health Monitor app received De Novo authorization from the FDA.

The Food and Drug Administration authorized the Samsung Galaxy Watch for the detection of signs of moderate to severe obstructive sleep apnea (OSA) in people aged 22 years and older.

This feature, which detects signs of sleep apnea using a compatible Samsung Galaxy Watch and phone, was the first of its kind to be authorized by the FDA following previous approval by Korea's Ministry of Food and Drug Safety (MFDS), announced last October in Korea.

The Food and Drug Administration has granted De Novo classification to a sleep apnea feature developed by Samsung for use via the Health Monitor app, according to a company press release.

Samsung's Galaxy Watch sleep apnea detection feature has been approved by the US Food and Drug Administration. The Samsung Health Monitor app can identify potential sleep apnea based on analysing the wearer's sleep patterns throughout the night.

Using a compatible Samsung Galaxy Watch and Phone, the new feature will detect signs of moderate to severe obstructive sleep apnea (OSA) in adults 22 years of age and older, empowering people to seek medical care.

Yes. Original Medicare helps pay 80% of the cost of the following equipment after you've met your Part B deductible: CPAP machine rental for a 3-month trial if you're newly diagnosed. CPAP rental for 13 months if you've been using it consistently (after 13 months, you'll own the CPAP machine)

The sensitivity of epoch-by-epoch sleep detection was 0.954; however, the specificity was 0.524. The sensitivity of each sleep stage estimation was 0.695 for light sleep, 0.612 for deep sleep, and 0.598 for REM sleep. The overall accuracy of GW3 in distinguishing the four-stage sleep epochs was 0.651.

To record your snoring tap the switch next to Record audio and place your smartphone near your head while sleeping. When you turn in for the night, your watch and phone will detect your snoring.

The watch uses a sensor to determine when you've started and stopped the sleep cycle and tracks the four stages of sleep (light sleep, deep sleep, rapid eye movement (REM) and awake time). You can also enable the watch to measure blood oxygen levels, or SpO2, and skin temperature.

What is the new treatment for sleep apnea in 2024? ›

Bottom line. The Inspire sleep apnea device is an innovative surgical implant using gentle electrical pulses to keep your airway open while you sleep. Unlike traditional CPAP machines, the Inspire doesn't require large equipment or a mask—just the implant and the remote to turn it on and off.

Best Overall

Most CPAP machines on the market today are fairly advanced, but the ResMed AirSense 11 AutoSet offers an assortment of features to help you breathe comfortably during sleep. As an APAP device, the pressure levels automatically adjust based on your breathing patterns.

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.

The Galaxy Watch detects OSA, specifically, which occurs when your airway partially or fully closes and you temporarily stop breathing. View Source (Another type, not yet detected by smart watches, is central sleep apnea, which happens when your brain doesn't send the right signals for breathing.)

The smartwatch received FDA clearance for its Irregular Heart Rhythm Notification (IHRN) function. Housed in the Samsung Health Monitor app, the upcoming feature detects AFib, a type of treated heart arrhythmia that causes the heart to beat too slowly, too fast, or in an irregular way.

About Vivos CARE oral appliances

The FDA-cleared suite of appliances includes the DNA oral appliance, mRNA oral appliance and mmRNA oral appliance. Data submitted to the FDA showed treatment results were better in patients with severe OSA compared to mild-to-moderate OSA. The average treatment time was 9.7 months.

Are home CPAP cleaners approved by the FDA? No home CPAP cleaning devices that use ozone gas or UV light have been approved or cleared by the FDA.

The Belun Sleep System is FDA cleared for in-home sleep apnea tests. The Belun Ring is a cableless photoplethysmography (PPG)-based wearable that is worn on the index finger while sleeping. It records patients' oxygen saturation, pulse rate, and actigraphy for up to 10 hours per night.

In June 2021, Philips Respironics (Philips) recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines because of potential health risks.