Vivos Therapeutics Nabs 510(k) Clearance for Sleep Apnea Device

Vivos Therapeutics has received the FDA’s 510(k) clearance for its mandibular repositioning nighttime appliance for treating mild-to-moderate obstructive sleep apnea.

The oral appliance addresses the dental anomalies and malformations associated with the condition that causes sleep-disordered breathing and snoring in adults.

Patients treated with the Vivos System “typically complete their therapy in 12 to 24 months and, in most cases, do not require lifetime intervention,” the company said.