FDA Grants Market Clearance to Vivos’ mmRNA Device for Treating Sleep Apnea

Posted: August 26, 2021
Edited by Dentaltown staff

HIGHLANDS RANCH, Colo.—Vivos Therapeutics, a medical technology company focused on developing and commercializing diagnostic and treatment modalities for patients suffering from sleep-disordered breathing, announced the U.S. Food and Drug Administration (FDA) has granted 510(k) market clearance to Vivos’ mmRNA (modified mandibular Repositioning Nighttime Appliance) device for treating mild to moderate OSA, sleep-disordered breathing and snoring in adults. This FDA clearance paves the way for expanded insurance reimbursement coverage for the mmRNA device, including Medicare, as well as for potential future government contracts and reimbursement from commercial payers that follow Medicare guidelines.
 
Vivos’ oral appliances address the dental tissue anomalies and malformations known to be associated with OSA. Patients treated with the Vivos System typically complete their therapy in 12 to 24 months and, in most cases, do not require lifetime intervention. 
 
“The FDA’s market clearance of Vivos’ newest device, the mmRNA appliance, represents a significant milestone in our ongoing efforts to provide the best possible treatment for people who continue to suffer needlessly from OSA, a debilitating condition that causes or contributes to a wide range of chronic health issues,” said Kirk Huntsman, Vivos chairman and CEO. “Next-generation products like the mmRNA are vital for allowing medical doctors and dentists to continue pushing forward in their joint mission to give patients a better alternative for effectively treating their OSA. Further, this FDA clearance for the mmRNA enables us to expand commercial insurance reimbursement, soon to include Medicare, making this a more cost-effective solution for patients suffering from OSA.”
 
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