Vivos Therapeutics hits major milestone with FDA clearance for treating severe sleep apnea

Vivos Therapeutics CEO Kirk Huntsman joined Steve Darling from Proactive to announce a significant milestone for the company with its first-ever 510(k) clearance from the US Food and Drug Administration (FDA). The clearance is for the treatment of severe obstructive sleep apnea (OSA) in adults using Vivos' removable CARE oral appliances.

This clearance covers Vivos' CARE appliances, which include the flagship DNA oral appliance, the mRNA oral appliance, and the mmRNA oral appliance.

Vivos is now the first company to receive FDA approval and bring to market a clear alternative treatment for patients with severe OSA, offering an alternative to continuous positive airway pressure (CPAP) therapy or surgical neurostimulation implants.

This achievement follows closely on the heels of Vivos' previous FDA 510(k) clearance granted just eleven months ago, allowing the company to treat mild-to-moderate OSA with its DNA oral appliance.

This recent clearance marks the first time the FDA has ever granted approval for an oral appliance to treat both moderate and severe OSA in adults aged 18 and older, in combination with positive airway pressure and/or myofunctional therapy as needed.

Vivos Therapeutics' dedication to advancing innovative treatments for sleep apnea underscores its commitment to improving the quality of life for individuals suffering from this condition. With this latest clearance, the company is positioned to provide an effective and accessible treatment option for a broader range of OSA patients, offering hope for improved sleep and overall well-being.

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