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

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

August 21, 2024 By Danielle Kirsh

SoClean 3+ next to a lit lamp in a bedroom.
[Image courtesy of SoClean]
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.

So far, SoClean has been issued over 150 patients worldwide, with emphasis on its bacterial reduction systems, methods, devices and designs.

The SoClean 3+ system is an over-the-counter device that can be purchased on the company’s website once marketing commences. It is currently established for use with the ResMed Mirage FX (nasal mask), ResMed ClimateLine Air (tubing) and SlimLine (tubing) for the ResMed AirSense 10. The company is working toward establishing additional hoses and masks for use with the SoClean 3+ bacterial reduction system.

Filed Under: Respiratory Tagged With: SoClean

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About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at [email protected].

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