{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-028778","form_type":"8-K","ticker":"BCDA","cik":"0000925741","company_name":"BioCardia, Inc.","filed_at":"2026-08-24T12:30:08+00:00","discovered_at":"2026-08-24T12:35:04.072563+00:00","generated_at":"2026-08-24T12:35:33.093306+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"BioCardia gets FDA confirmation of Helix catheter meeting minutes; De Novo submission planned this quarter","bullets":["FDA confirmed final meeting minutes from May 2026 Pre-Submission Meeting on Helix Transendocardial Delivery Catheter System.","BioCardia intends to submit follow-on pre-submission for Helix this quarter, incorporating agency advice.","Successful De Novo clearance could enable independent Helix market clearance and enhance partnering for cell/gene/protein therapeutics.","CEO Peter Altman stated the submission could enable Helix approval via De Novo pathway."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-028778","json":"https://secwatch.observer/filing/0001437749-26-028778.json","markdown":"https://secwatch.observer/filing/0001437749-26-028778.md","text":"https://secwatch.observer/filing/0001437749-26-028778.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/925741/000143774926028778/0001437749-26-028778-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/925741/000143774926028778/bcda20260821_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-24T12:35:33.093306+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"}