Recent Updates — BCDA

The FDA has accepted BioCardia's revised De Novo pre-submission package for the Helix transendocardial delivery catheter, which is intended for the therapeutic and diagnostic agent delivery to the heart. Following initial meetings in May 2026 where the agency raised no safety concerns, BioCardia incorporated feedback into a September resubmission that was subsequently accepted. The company expects FDA substantive review with written feedback and a meeting to discuss approval via the De Novo pathway later this quarter. Marketing clearance could expand opportunities for BioCardia to partner with developers of investigational cells, genes, and protein therapeutics requiring targeted cardiac delivery. BioCardia is developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases.

On October 1, 2026, BioCardia, Inc. announced the completion of a revised Pre-Submission to the FDA Center for Devices and Radiological Health (CDRH) under its Q-Submission program regarding the approval of its Helix Catheter for therapeutic and diagnostic agent delivery to the heart. The submission incorporates advice from an initial meeting in May 2026, where the FDA identified two pathways for marketing clearance and raised no concerns regarding safety data or device performance. The FDA targets providing written feedback within 70 calendar days. BioCardia operates in the biotechnology industry, developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases.