SoClean wins FDA de novo nod for CPAP, ventilation hose cleaner

SoClean this week announced it was granted FDA de novo clearance for its at-home CPAP mask and ventilation hose cleaner SoClean 3+.

Peterborough, N.H.-based SoClean designed SoClean 3+ to be used as an adjunct to reduce bacterial populations on certain compatible home-use CPAP masks and ventilation hoses after cleaning. It has demonstrated a 99.9% reduction in bacterial populations in CPAP hoses and masks.

“Sleep apnea is a growing issue worldwide, which impacts user’s ability to get a proper night’s rest. Ensuring bacteria in CPAP hoses and masks can be easily reduced following cleaning is essential for daily use and maintenance by users,” CEO Robert Wilkins said in a news release.

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