BioCardia Announces FDA Acceptance of De Novo Pre-Submission Package for Helix™ Catheter Marketing Clearance FDA Substantive Review and Meeting Expected this Quarter
BioCardia announced that the FDA accepted its pre-submission package for marketing clearance of the Helix catheter, intended for therapeutic and diagnostic agent delivery. The headline says FDA substantive review and a meeting are expected this quarter.
Why it matters — The FDA’s acceptance marks a regulatory step in BioCardia’s effort to pursue marketing clearance for the Helix catheter.