FDA accepts BioCardia's Helix catheter pre-submission package
BCDA•The FDA accepted BioCardia's De Novo pre-submission package for its Helix catheter, with substantive review, written feedback and a meeting expected this quarter.
BCDA•BCDA•BCDA•The FDA accepted BioCardia's De Novo pre-submission package for its Helix catheter, with substantive review, written feedback and a meeting expected this quarter.
The FDA accepted BioCardia's De Novo pre-submission package seeking marketing clearance for its Helix catheter, which is intended to deliver therapeutic and diagnostic agents. Substantive review, written feedback and a meeting to discuss De Novo clearance are expected this quarter.
