Yahoo · Oct 19, 2026
BioCardia Announces FDA Acceptance of De Novo Pre-Submission Package for Helix™ Catheter Marketing Clearance FDA Substantive Review and Meeting Expected this Quarter
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. In May 2026, the Company and FDA met and reviewed our initial De Novo pre-submission package. FDA agreed that there are t


