BioCardia Announces FDA Acceptance of De Novo Pre-Submission Package for Helix™ Catheter Marketing Clearance FDA Substantive Review and Meeting Expected this Quarter

globe_newswire · 2026-10-19

$BCDA

SUNNYVALE, Calif., Oct. 19, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. [NASDAQ: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the FDA has accepted its pre-submission package for marketing clearance of its Helix catheter (“Helix”) intended for therapeutic and diagnostic agent delivery.

Sector coverage: Healthcare · Biotechnology

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