Vivos Receives FDA 510(k) Clearance For Removable Oral Appliances For Severe OSA

(RTTNews) - Medical device and technology company Vivos Therapeutics, Inc. (VVOS) Wednesday announced that it has been granted 510(k) clearance from the FDA for treating severe obstructive sleep apnea or OSA in adults using its removable CARE oral appliances.

Eleven months back, the FDA had granted Vivos 510(k) clearance for the DNA oral appliance to treat mild-to-moderate obstructive sleep apnea.

The company had submitted statistically significant data to the FDA from 73 severe obstructive sleep apnea patients showing that 80 percent of patients experienced an improvement of at least 1 classification or at least a 50 percent improvement in the Apnea-Hypopnea Index, and 97 percent of patients improved or stayed the same. The average treatment time was just 9.7 months.