Vivos Therapeutics gains FDA 510(k) clearance for sleep apnea treatment device
Betsy Goodfellow | November 30, 2023 | News story | Medical Communications | Devices, FDA, Vivos Therapeutics, sleep apnea
Vivos Therapeutics has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Vivos’ removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances for the treatment of severe obstructive sleep apnea (OSA) in adult patients.
Vivos now becomes the first company to have approved and to market a clear alternative treatment to CPAP or surgical neurostimulation implants for patients who have severe OSA.
Dr David McCarty, renowned medical sleep specialist, author and lecturer, commented: “Make no mistake: this is a huge development on the landscape of treatments for OSA. As the medical profession has gained a better understanding of the complex factors contributing to OSA, we now recognise that a critical component to this condition is the form and functionality of the oral vault. This is where medical collaboration with an airway-centered dentistry approach like Vivos offers is a game-changer. This decision by the FDA could be life changing for patients who suffer from severe OSA and for whom other treatments have failed.”
Kirk Huntsman, chairman and chief executive officer of Vivos Therapeutics, added: “This achievement is a pivotal milestone for Vivos, and elevates our proven treatment options right into the mainstream of sleep medicine. 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.”
Betsy Goodfellow
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