{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-24-036942","form_type":"8-K","ticker":"VVOS","cik":"0001716166","company_name":"Vivos Therapeutics, Inc.","filed_at":"2024-09-18T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.235445+00:00","generated_at":"2026-05-31T03:59:10.206489+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Vivos Therapeutics receives first FDA 510(k) clearance for oral device to treat pediatric OSA","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-24-036942","json":"https://secwatch.observer/filing/0001493152-24-036942.json","markdown":"https://secwatch.observer/filing/0001493152-24-036942.md","text":"https://secwatch.observer/filing/0001493152-24-036942.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1716166/000149315224036942/0001493152-24-036942-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1716166/000149315224036942/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T03:59:10.206489+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}