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 the FDA has accepted its De Novo pre-submission package for marketing clearance of the Helix transendocardial delivery catheter. FDA raised no concerns on safety data or performance in earlier meetings, and substantive review with written feedback plus a meeting on the De Novo pathway is expected this quarter.
Key figures
- Drug Name
- Helix transendocardial delivery catheter
- Phase Of Trial
- De Novo pre-submission (FDA CDRH)
- Clinical trials
- fifteen
- Patients studied
- nearly five hundred
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