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Australia clears Vivos technology to treat obstructive sleep apnea

15 July 2022 | News

Vivos Therapeutics receives multiple regulatory clearances in Australia for its entire line of oral appliances

Image credit: shutterstock

Image credit: shutterstock

Vivos Therapeutics has received multiple Class I clearances by the Therapeutic Goods Administration (TGA) of Australia, for multiple indications to include the treatment of snoring and obstructive sleep apnea (mild, moderate and severe) for both adults and children for its series of oral appliances.

According to Kirk Huntsman, co-founder and CEO of Vivos Therapeutics, "We are progressively moving forward with other domestic and international regulatory agencies with high expectations that our applications will be as well received as they have been in Australia. Poor sleep is a global epidemic. Vivos has developed a safe, comfortable, non-invasive, non-surgical solution, and we intend to offer it worldwide."

Australia follows the standards applied by the International Organization for Standardization (ISO), which is currently made up of 165 members/countries. These new clearances will allow Vivos to share its innovative technology and distribute devices that will help not only adults, but also children who suffer from sleep breathing disorders. These latest clearances include all classes of obstructive sleep apnea (OSA) as defined by the newly received Global Medical Device Nomenclature (GMDN) Vivos has received in Australia.

These clearances allow Vivos Therapeutics to distribute its appliances for several approved indications inclusive of snoring, sleep-disordered breathing and obstructive sleep apnea within the Australian market.

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