BioCardia files revised De Novo pre-submission to FDA for Helix Catheter approval

BioCardia, Inc.

Revised Pre-Submission to FDA CDRH under Q-Submission program covers the Helix Catheter for therapeutic and diagnostic agent delivery to the heart.
In May 2026 FDA agreed there are two pathways for Helix marketing clearance and raised no concerns on safety data, device performance, or agent compatibility.
FDA confirmed and accepted the meeting minutes in August 2026; revised submission incorporates FDA CDRH advice from those minutes.
Helix data spans 15 clinical trials and nearly 500 patients; FDA targets acceptance/refusal review in 15 days and feedback or meeting within 70 days.
Independent clearance could expand partnering with developers of cell, gene and protein therapeutics needing targeted heart delivery.

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