India, Oct. 19 -- BioCardia, Inc. (BCDA), a biotechnology company developing cellular and cell-derived therapies for cardiovascular and pulmonary diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted its revised De Novo pre-submission package for marketing clearance of its Helix catheter.
The submission follows discussions with the FDA in May 2026, when the agency identified two potential pathways for marketing clearance and raised no concerns regarding the catheter's safety data, performance or compatibility with general classes of therapeutic agents.
BioCardia revised and resubmitted the package in September, incorporating FDA feedback. The company expects substantive FDA review, written feedback and a follow...