Vivos Therapeutics DNA oral device gets FDA nod for obstructive sleep apnea
Vivos Therapeutics has secured the US Food and Drug Administration (FDA) 510(k) clearance for its DNA oral device indicated for obstructive sleep apnea (OSA) treatment.
The 510(k) approval for the DNA appliance as a Class II device marks the third FDA clearance for Vivos’ oral devices and the first clearance for the medical technology company’s proprietary core technology.
The FDA clearance is backed by clinical findings which demonstrated that the DNA oral device successfully resolved obstructive sleep apnea in 28% of user and increased the width of palate in 97% of participants. Besides, the device was shown to improve airway in 86% of patients and in 63% of patients by one apnea hypopnea index classification that is severe to moderate, moderate to mild, or mild to no obstructive sleep apnea.
Kirk Huntsman — Vivos Therapeutics Chairman and CEO said: “For the first time, the FDA has formally recognized the benefits of our proprietary core technology in our DNA appliance (without mandibular advancement) as an effective treatment for mild-to-moderate OSA in adults.
“The FDA now joins other international regulatory bodies in recognizing the efficacy of our patented technology in the reduction and resolution of many of the symptoms of OSA that result from a lack of development of the jaws and oral cavity.”
Vivos Therapeutics gets FDA 510(k) clearance for its DNA oral device in obstructive sleep apnea. Photo courtesy of The U.S. Food and Drug Administration/Wikimedia Commons.
The DNA oral device is also used for orthodontic treatment, including expansion of the jaw and positioning of teeth in children and adults.
Earlier, Vivos Therapeutics secured FDA Class II devices approval for the company’s mandibular Repositioning Nighttime Appliance (mRNA)and modified mandibular Nighttime Appliance (mmRNA) for the treatment of mild-to-moderate obstructive sleep apnea and/or snoring in adults.