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inSleep Health receives FDA 510(k) approval for Cloud9 anti-snoring system

Medical device firm inSleep Health has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Cloud9 anti-snoring system.


Cloud9, which is a prescription device for home use, has been developed to reduce or eliminate simple snoring in adults.

The system is said to provide comfortable airflow at very low airway pressure and it features new sports-styled air circuit and small nasal interface that serves as the mask.

inSleep Health founder and CEO Michael Gusky said: "We expect physicians and heath care professionals to be elated knowing they can finally treat their patients who snore.

"We learned from doctors the frequency of someone complaining that their wife, husband or significant other is exhausted from being awakened by their partner’s snoring."

inSleep Health is involved in developing and commercializing patented products using low continuous air pressure to decrease or eliminate simple snoring during times of rest or sleep.

Image: inSleep Health’s Cloud 9 Anti-Snoring System. Photo: courtesy of PRNewswire/ inSleep Health.