Sleep Apnoea Articles & Analysis
-
Acurable receives US FDA clearance for its home sleep apnoea testing device AcuPebble SA100
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 ...
-
AcuPebble SA100 offers automated sleep apnea diagnosis equivalent to cardiorespiratory polygraphy
AcuPebble SA100 is clinically equivalent to cardiorespiratory polygraphy for the automated diagnosis of obstructive sleep apnea (OSA) at home, a paper published in the BMJ Open has revealed. A powered clinical trial conducted by the Royal Free Hospital in London demonstrated both the accuracy and usability of the small device, which has the potential to open more efficient patient pathways for ...
Need help finding the right suppliers? Try XPRT Sourcing. Let the XPRTs do the work for you