Vivos Therapeutics receives first ever FDA 510(k) clearance for oral device treatment of severe obstructive sleep apnea.
Vivos Therapeutics, Inc. announced that it has been granted 510(k) clearance from the FDA for treating severe obstructive sleep apnea (OSA) in adults using the Vivos’ removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances
Vivos’ CARE appliances include the flagship DNA oral appliance, the mRNA oral appliance and the mmRNA oral appliance.
As a result of this FDA clearance, Vivos becomes the first company ever to have approved and bring to market a clear alternative treatment to CPAP (continuous positive airway pressure ) or surgical neurostimulation implants for patients with severe OSA. This latest clearance comes just eleven 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 FDA 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.
Nationally renowned medical sleep specialist, author and lecturer, Dr. David McCarty, MD, elaborated on the impact of this landmark decision, stating “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 recognize 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.”
Related news and insights
RAPT Therapeutics, Inc. announced that the FDA has verbally notified the company that a clinical hold has been placed on the company’s Phase IIb trial of zelnecirnon (RPT193) in atopic dermatitis and its Phase IIa trial in asthma
Bristol Myers Squibb announced that the FDA has accepted for priority review the supplemental new drug application (sNDA) for Krazati (adagrasib) in combination with cetuximab for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC)
Tenax Therapeutics, Inc., a Phase III, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, announced it has secured global development, commercial, and IP rights to oral and subcutaneous levosimendan for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF)