Vivos Therapeutics gets 1st FDA clearance for sleep apnea device

Vivos Therapeutics was recently granted FDA 510(k) clearance for a device used to treat severe obstructive sleep apnea.

Vivos Therapeutics develops treatments for patients with dentofacial abnormalities, mild-to-moderate obstructive sleep apnea and snoring.

The company was granted the clearance for its removable Complete Airway Repositioning and/or Expansion oral appliances, according to a Nov. 29 news release.

Vivos Therapeutics said it is the first company to gain FDA clearance for an alternative treatment to CPAP machines or surgical neurostimulation implants for patients with severe obstructive sleep apnea.

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