(via NewsDirect)
This clearance covers Vivos'
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.
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