Vivos Therapeutics receives first FDA 510(k) clearance for oral device to treat pediatric OSA

Vivos Therapeutics, Inc.

FDA cleared Vivos' DNA appliance to treat moderate to severe OSA and snoring in children aged 6–17.
Up to 10.1 million U.S. children estimated to suffer from pediatric OSA; current standard is adenotonsillectomy.
Clinical study (n=48) showed 62.7% improvement in AHI, 58% snoring reduction, no safety concerns.
Company plans to leverage clearance via new marketing & distribution alliances with medical sleep providers.
Believed to be first-ever FDA clearance of an oral medical device for pediatric OSA treatment.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.