FDA Clears Vivos Therapeutics' Oral Device for Sleep Apnea Treatment
Vivos Therapeutics has received clearance from the US FDA for its oral device designed to treat severe obstructive sleep apnea (OSA). This marks the first-ever clearance for an oral appliance to treat moderate and severe OSA in adults. The device gradually repositions the airway's hard and soft tissues, optimizing its function and flow. Study data supported the FDA's decision, showing a 50% improvement in the index used to determine the presence and severity of the disease. Shares of Vivos Therapeutics more than doubled in premarket trading following the announcement.