Vivos receives FDA 510k clearance to treat pediatric sleep apnea, snoring

Vivos Therapeutics announced receipt of what is believed to be the first ever U.S. Food and Drug Administration, FDA, 510(k) clearance to treat moderate to severe OSA and snoring in children using Vivos’ proprietary flagship oral medical device. Kirk Huntsman, Chairman and CEO of Vivos, stated, “The FDA 510(k) clearance announced today is, to our knowledge, the first time any oral medical device has ever been approved to treat moderate to severe OSA in children. This clearance is the latest in a series of regulatory wins for Vivos, not just in the United States, but globally. It represents the culmination of a growing body of research and regulatory approvals confirming and validating the extraordinary potential and efficacy of our proprietary Vivos technology. In addition, this landmark clearance opens up an exciting and vast new market and enables us to directly address the needs of millions of children who currently suffer from sleep-related breathing disorders such as OSA.”