FDA clears Vivos device for OSA
By HME News Staff
Updated 9:49 AM CST, Thu November 30, 2023
LITTLETON, Colo. – Vivos Therapeutics has received 510(k) clearance from the U.S. Food and Drug Administration for treating severe obstructive sleep apnea in adults using its removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances. CARE appliances include the flagship DNA oral appliance, the mRNA oral appliance and the mmRNA oral appliance. “This achievement is a pivotal milestone for Vivos and elevates our proven treatment options right into the mainstream of sleep medicine,” said Kirk Huntsman, chairman and CEO of Vivos. “It is even more important for the millions of severe OSA patients who are desperate for an effective alternative treatment. Before this, severe OSA patients’ only realistic treatment options were CPAP, neurostimulation implants or other invasive surgeries. Today, they have what we believe is a far more desirable option that is very affordable and doesn’t require surgery or a lifetime of nightly use and intervention.” This latest clearance comes just 11 months after the FDA granted Vivos 510(k) clearance for the DNA oral appliance to treat mild-to-moderate OSA, and represents the first time the agency has ever granted an oral appliance a clearance to treat moderate and severe OSA in adults, 18 years of age and older, along with positive airway pressure (PAP) and/or myofunctional therapy, as needed.
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