{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-031011","form_type":"8-K","ticker":"BCDA","cik":"0000925741","company_name":"BioCardia, Inc.","filed_at":"2026-09-23T13:15:10+00:00","discovered_at":"2026-09-23T13:16:04.666921+00:00","generated_at":"2026-09-23T13:16:15.392653+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.5,"calibrated_materiality_score":0.5,"confidence":"high","headline":"BioCardia updates FDA Helix pre-submission and PMDA CardiAMP HF Shonin timing","bullets":["PMDA Shonin pre-market submission targeted for Q4 2026; possible market clearance by Q4 2027.","FDA Helix follow-on De Novo pre-submission intended this quarter; FDA feedback within 70 calendar days.","CardiAMP HF II trial actively enrolling at four U.S. centers; CBER indicates study may support a PMA.","Company provided detailed responses to PMDA consultation questions; working on QMS and Foreign Manufacturer Registration."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-031011","json":"https://secwatch.observer/filing/0001437749-26-031011.json","markdown":"https://secwatch.observer/filing/0001437749-26-031011.md","text":"https://secwatch.observer/filing/0001437749-26-031011.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/925741/000143774926031011/0001437749-26-031011-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/925741/000143774926031011/bcda20260923_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-23T13:16:15.392653+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"}