BioCardia Files Revised De Novo Pre-Submission for FDA Approval of Helix™ Catheter
BioCardia has completed a revised De Novo pre-submission to the FDA CDRH for approval of its Helix biotherapeutic delivery catheter, incorporating FDA advice from accepted May 2026 meeting minutes. The FDA raised no concerns on Helix safety data, device performance, or agent compatibility, and agreed there are two potential marketing-clearance pathways. The agency targets an initial acceptance/refusal review within 15 calendar days and written feedback or a meeting within 70 days.
Key figures
- Drug Name
- Helix Catheter
- Phase Of Trial
- Pre-Submission (Q-Submission program)
- Clinical trials
- 15
- Patients studied
- nearly 500
- Fda initial review days
- 15
- Fda written feedback days
- 70
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