inSleep Gets FDA Nod for Cloud9 System
The FDA has cleared Weston, Fla.-based inSleep Health’s anti-snoring system as a prescription device for home use.
Intended to reduce or eliminate simple snoring, which the company says affects more than 35 million U.S. consumers, the Cloud9 system uses continuous low positive airway pressure and includes a novel air circuit and a small nasal interface that serves as a mask.
Alan Schwartz of The Johns Hopkins University says in a prepared statement that use of the system helps with marked reductions or the complete elimination of snoring in those without sleep apnea, according to trial results.
The company expects to make the system commercially available next year. It is the first product from inSleep available with a prescription. — Elizabeth Hollis