FDA Accepts BioCardia Helix Catheter De Novo Pre-Submission
The FDA accepted BioCardia’s De Novo pre-submission for marketing clearance of its Helix catheter. Substantive review and an FDA meeting are expected this quarter.
The FDA accepted BioCardia’s De Novo pre-submission for marketing clearance of its Helix catheter. Substantive review and an FDA meeting are expected this quarter.