Combo CPAP/Filter Mask by Circadiance Gets FDA Emergency Use Authorization

The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to CPAP mask maker Circadiance, under the umbrella EUA for ventilators, for its SleepWeaver Prevent CPAP Mask. The product is a CPAP mask that was modified by combining it with an N95.

The SleepWeaver Prevent Nasal Mask is intended to provide an interface for CPAP or bilevel therapy. This mask is intended for single-patient reuse in the home and single-patient reuse in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs. The filter mask present in SleepWeaver Prevent is intended to filter exhaled air to reduce the likelihood that the exhaled air may contaminate the room air around the person using the mask.