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