{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-24-033343","form_type":"8-K","ticker":"NUWE","cik":"0001506492","company_name":"Nuwellis, Inc.","filed_at":"2024-07-17T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.296993+00:00","generated_at":"2026-05-31T20:11:58.774604+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Nuwellis adds risk factor on off-label Aquadex use in neonates under 20 kg","bullets":["Aquadex System cleared only for patients ≥20 kg, but is being modified for neonates/kidney failure infants.","FDA may view company communications as off-label promotion, risking untitled letters, fines, or criminal penalties.","Off-label promotion could trigger False Claims Act lawsuits, exclusion from Medicare/Medicaid, and corporate integrity agreements.","Updated corporate presentation posted on IR website; no specific financial or strategic changes disclosed."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-24-033343","json":"https://secwatch.observer/filing/0001140361-24-033343.json","markdown":"https://secwatch.observer/filing/0001140361-24-033343.md","text":"https://secwatch.observer/filing/0001140361-24-033343.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1506492/000114036124033343/0001140361-24-033343-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1506492/000114036124033343/ef20032513_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T20:11:58.774604+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"}