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.
