BioCardia, Inc. announced on October 19, 2026, that the U.S. Food and Drug Administration (FDA) has accepted the company's pre-submission package for marketing clearance of its Helix catheter. The Helix is a transendocardial delivery catheter designed for the minimally invasive targeted delivery of therapeutic and diagnostic agents to the heart.
The FDA acceptance follows a series of interactions between BioCardia and the agency. In May 2026, the company and the FDA met to review an initial De Novo pre-submission package. At that meeting, the FDA identified two potential pathways for marketing clearance and raised no concerns regarding the product's safety data, performance, or compatibility with general classes of agents. The FDA confirmed the meeting minutes in August 2026.
In September 2026, BioCardia revised the De Novo pre-submission package based on advice from the FDA's Center for Devices and Radiological Health (CDRH) and resubmitted it. The FDA has now accepted this revised package.
BioCardia stated that it expects to receive substantive review with written feedback from the FDA this quarter, followed by a meeting to discuss approval via the De Novo pathway. The company noted that the extensive clinical data and safety profile from fifteen clinical trials, including nearly five hundred patients, will be used to demonstrate that follow-on catheters meet the necessary safety and clinical experience standards.
BioCardia, headquartered in Sunnyvale, California, develops cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases. The company’s biotherapeutic platforms include CardiAMP autologous and CardiALLO allogeneic cell therapies. Marketing clearance of the Helix catheter is intended to expand BioCardia’s opportunities to partner with developers of investigational cells, genes, and protein therapeutics requiring targeted delivery to the heart.
