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BioCardia and FDA Align on Helix Transendocardial Delivery Catheter Clearance Pathways
SUNNYVALE, Calif., May 08, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the outcome of its Pre-Submission Meeting with FDA on the Helix Transendocardial Delivery Catheter System (Helix). FDA agreed that there are two pathways for Helix marketing clearance and raised no concerns on Helix safety data, device performance, or compatibility with general cl
About this update from Biocardia, Inc.
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