secwatch.observer — SEC 8-K summary
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Issuer:     BioCardia, Inc. (BCDA)
CIK:        0000925741
Form:       8-K
Filed at:   2026-09-23T13:15:10+00:00
Accession:  0001437749-26-031011
Event type: regulatory
Sentiment:  neutral
Materiality: 0.50
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BioCardia updates FDA Helix pre-submission and PMDA CardiAMP HF Shonin timing
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/925741/000143774926031011/0001437749-26-031011-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/925741/000143774926031011/bcda20260923_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-26-031011

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer