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News
- BioCardia receives FDA acceptance of its De Novo pre-submission package for Helix catheter marketing clearance, with substantive review and a meeting expected this quarterOct 19, 2026
- BioCardia presents the CardiAMP HF II trial design at the Heart Failure Society of America Annual Scientific MeetingOct 7, 2026
- BioCardia files a revised FDA De Novo pre-submission for the Helix transendocardial delivery catheterOct 1, 2026
- BioCardia says Japan PMDA guidance supports regulatory filing for CardiAMP cell therapy in ischemic heart failureMay 28, 2026
- BioCardia presents CardiAMP trial data showing durable exercise and angina improvements in chronic myocardial ischemiaMay 21, 2026