{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-25-019186","form_type":"8-K","ticker":"NRXS","cik":"0001933567","company_name":"Neuraxis, INC","filed_at":"2025-10-24T23:59:59+00:00","discovered_at":"2026-05-14T18:02:41.091491+00:00","generated_at":"2026-05-17T02:22:38.414766+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":"Neuraxis gets FDA 510(k) clearance for PENFS to treat functional dyspepsia in ages 8+","bullets":["FDA cleared Neuraxis' PENFS for functional abdominal pain associated with functional dyspepsia and nausea in patients 8 years and older.","This is the first FDA clearance or approval specifically addressing functional dyspepsia in adults.","Clearance based on RCTs and real-world evidence; FDA extrapolated pediatric data to adults.","Company increased ATM offering from $3.3M to $6.27M; no shares sold under prior agreement."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-25-019186","json":"https://secwatch.observer/filing/0001493152-25-019186.json","markdown":"https://secwatch.observer/filing/0001493152-25-019186.md","text":"https://secwatch.observer/filing/0001493152-25-019186.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1933567/000149315225019186/0001493152-25-019186-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1933567/000149315225019186/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T02:22:38.414766+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"}