Please provide your email address to receive an email when new articles are posted on . The FDA has granted de novo clearance to SoClean 3+, an over-the-counter bacterial reduction device for certain ...

The U.S. FDA caught up with four makers of CPAP cleaning machines in the form of warning letters advising the manufacturers that the claims made for their systems fall under the definition of a ...

Device servicing by third parties has been topical of late, although not in the context of continuous positive airway pressure (CPAP) systems. That seems likely to change thanks to the ongoing recall ...