BioCardia says FDA accepted Helix catheter De Novo pre-submission; review meeting expected this quarter

BioCardia, Inc.

• FDA accepted BioCardia's revised De Novo pre-submission package for marketing clearance of the Helix transendocardial delivery catheter, per the Oct. 19, 2026 release.
• In May 2026 FDA agreed two pathways exist for Helix clearance and raised no concerns on the product's safety data, performance, or compatibility with general classes of agents.
• FDA confirmed the meeting minutes in August 2026; BioCardia revised and resubmitted the package in September 2026 incorporating CDRH advice.
• Substantive review with written FDA feedback, followed by a meeting to discuss De Novo approval, is expected this quarter.
• Helix data covers 15 clinical trials and nearly 500 patients; clearance could expand partnering with cell, gene and protein therapeutic developers needing heart delivery.