Vivos Therapeutics Files for FDA Clearance for Sleep-Disorder Device

Vivos Therapeutics is seeking the FDA’s 510(k) marketing clearance for its modified mandibular Repositioning Nighttime Appliance, an oral device for treatment for sleep-disordered breathing.

The company hopes to receive agency clearance that would allow the oral device to be used for treating mild-to-moderate obstructive sleep apnea, sleep-disordered breathing and snoring in adults.

The company also expects to request that its device be added to the Centers for Medicare and Medicaid Services’ list of approved sleep apnea appliances if it gets FDA clearance. The agency’s review is expected to take three to six months.