Yahoo · Oct 1, 2026
BioCardia Files Revised De Novo Pre-Submission for FDA Approval of Helix™ Catheter
SUNNYVALE, Calif., Oct. 01, 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 reported it has completed its revised Pre-Submission to FDA Center for Devices and Radiological Health (CDRH) under its Q-Submission program for the approval of its Helix Catheter (“Helix”) for therapeutic and diagnostic agent delivery to the heart. In May 2026, the Company and FDA met and


