Vivos gets FDA market clearance for oral sleep apnea device

 Part of the Vivos System Treatment, the mmRNA Device Represents a Highly Effective Non-Surgical, Non-Invasive and Non-Pharmaceutical Alternative for Patients Suffering from OSA

Approval Expands Insurance Reimbursement Potential, Including the Opportunity for Medicare Coverage for mmRNA

HIGHLANDS RANCH, Colo., Aug. 23, 2021 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (the “Company” or “Vivos”) (NASDAQ: VVOS), a medical technology company focused on developing and commercializing innovative diagnostic and treatment modalities for patients suffering from sleep-disordered breathing, including mild to moderate obstructive sleep apnea (OSA), today 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.

https://finance.yahoo.com/news/fda-grants-510-k-market-113000440.html