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Friday, May 8, 2026

FDA meeting IDs marketing clearance pathways for BioCardia Helix Transendocardial Delivery Catheter

 

FDA pre-submission meeting identifies two marketing clearance pathways for BioCardia's Helix Transendocardial Delivery Catheter

  • FDA raised no concerns about the Helix catheter's safety, performance, or compatibility during the pre-submission meeting.
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