AirAvant device receives FDA clearance

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Thursday, October 11, 2018

DEERFIELD BEACH, Fla. – AirAvant Medical has received 510(k) clearance from the Food and Drug Administration for its Bongo Rx. Used in the treatment of mild to moderate sleep apnea, the Bongo Rx has been shown to significantly reduce AHI levels, according to a press release. The device is small and portable, and requires no PAP machine, hoses, headgear or electricity; it seals comfortably in the nose and works by creating backpressure when the user exhales. “We recognize that people need to have the ability to treat their sleep apnea comfortably and conveniently, no matter where they are—in a bed, on a train, on a plane, or even catching a quick nap in a chair or on the couch,” said Javier Collazo, vice president. The Bongo Rx will be featured in the New Product Pavilion at Medtrade in Atlanta next week.