Sleep Apnea Detection Articles & Analysis
2 news found
AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnoea (OSA) in adults, has obtained FDA 510(k) clearance as a Class II medical device in the USA. The device, which received a CE Mark as a Class IIa medical device in 2020, was developed and is commercialised by UK-based medical device company Acurable and builds on more than ten ...
The funds will be used to further develop research and then seek FDA approval for a wearable sleep product to screen for sleep apnea. This would be a wireless, wearable, over the counter sleep apnea product. More than 18 million adult Americans have sleep apnea, according to the ...