FDA Cleared Oral Device for Severe Sleep Apnea From Vivos Therapeutics
On November 29, 2023, Vivos Therapeutics announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Vivos’s removable CARE (Complete Airway Repositioning and Expansion) oral appliances developed for treating severe obstructive sleep apnea (OSA).
With this FDA approval, Vivos Therapeutics became the first firm to approve and launch a viable therapy option for patients suffering with severe OSA other than CPAP or surgical neuro-stimulation implants. This latest approval marks the first time the FDA has ever approved an oral device to treat moderate and seve...
