{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-23-030531","form_type":"8-K","ticker":"FEED","cik":"0001326706","company_name":"ENvue Medical, Inc.","filed_at":"2023-08-29T23:59:59+00:00","discovered_at":"2026-05-14T18:03:33.584883+00:00","generated_at":"2026-06-11T02:17:52.979470+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"CMS denies Medicare/Medicaid reimbursement for NanoVibronix PainShield device","bullets":["CMS concluded PainShield does not fall within DMEPOS benefit category, so not reimbursable under Medicare/Medicaid.","CEO Brian Murphy says company plans to develop action plan and resubmit application for additional CMS review.","Company continues distribution in workers' comp, personal injury, and VA markets while addressing CMS concerns.","NanoVibronix believes PainShield benefits over 150M Medicare/Medicaid patients but faces reimbursement setback."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-23-030531","json":"https://secwatch.observer/filing/0001493152-23-030531.json","markdown":"https://secwatch.observer/filing/0001493152-23-030531.md","text":"https://secwatch.observer/filing/0001493152-23-030531.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1326706/000149315223030531/0001493152-23-030531-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1326706/000149315223030531/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-11T02:17:52.979470+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"}