AirAvant Sleep Apnea Solution Receives FDA Clearance

DEERFIELD BEACH, Fla. (October 9, 2018)—AirAvant Medical announced that its flagship product, the Bongo Rx, has received FDA 510(k) clearance for the treatment of mild to moderate obstructive sleep apnea (OSA). 

Years of research, development and testing have yielded a device that is small, portable and requires no CPAP machine, hoses, headgear or electricity/battery power, according to the company. The Bongo Rx is designed to seal comfortably in the nose and works by creating back pressure when a person with OSA exhales.

After clinical testing, it was demonstrated the Bongo Rx reduced the apnea hypopnea index or AHI levels, which is the measurement for the number of apneas and hypopneas recorded per an hour of sleep, according to the company. AirAvant Medical developed the Bongo Rx to be convenient and transportable. Its small size allows the user to carry it in a shirt pocket or purse, so the device can be used anywhere at any time.

“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, AirAvant vice-president. “For compliant CPAP patients, the Bongo Rx may provide a supplemental treatment option to complement their lifestyle. For non-compliant CPAP patients, the Bongo Rx may provide a patient-friendly, non-cumbersome treatment option to get them refocused and reengaged on treating their obstructive sleep apnea.”

The Bongo Rx will be featured at Medtrade in Atlanta, Georgia, from Oct. 15–17.

Visit airavant.com for more information