The pre-market prototype of the AIM device was recently tested under simulated patient conditions at a patient-simulation lab used to test airway devices, following GLP regulations and Reviewer Guidance for Premarket Notification Submissions.
The results of the testing and the data collected, confirm that AIM’s oxygen delivery and capnography outperformed the commonly used mask device in a side-by-side comparison. The improved functionality and added patient-safety features establish AIM as a superior alternative to many other sedation devices currently in clinical use.