{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-24-033392","form_type":"8-K/A","ticker":"NUWE","cik":"0001506492","company_name":"Nuwellis, Inc.","filed_at":"2024-07-17T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.296402+00:00","generated_at":"2026-05-31T20:11:18.218002+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.25,"calibrated_materiality_score":0.25,"confidence":"low","headline":"Nuwellis adds off-label use risk factor and updates investor presentation","bullets":["Filed 8-K/A to replace corporate presentation; updated version posted to investor website.","Added risk factor detailing potential penalties from off-label promotion of Aquadex system, including use in neonates.","Risk factor warns of FDA enforcement, False Claims Act suits, and exclusion from Medicare/Medicaid for off-label marketing.","No changes to financial statements or other disclosures from prior 10-Q; no new business results provided.","Company states its off-label communications are compliant but acknowledges regulatory authorities may disagree."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-24-033392","json":"https://secwatch.observer/filing/0001140361-24-033392.json","markdown":"https://secwatch.observer/filing/0001140361-24-033392.md","text":"https://secwatch.observer/filing/0001140361-24-033392.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1506492/000114036124033392/0001140361-24-033392-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1506492/000114036124033392/ef20032557_8ka.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T20:11:18.218002+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"}