BioCardia Files Revised De Novo Pre-Submission for FDA Approval of Helix™ Catheter
Key Highlights
- ➤Revised De Novo pre-submission filed for FDA approval of Helix catheter (BCDA)
- ➤FDA raised no concerns about Helix safety, performance, or agent compatibility
- ➤Helix data spans 15 clinical trials and nearly 500 patients
- ➤FDA targets initial review within 15 calendar days
- ➤FDA aims to issue feedback or hold a meeting within 70 calendar days
SUNNYVALE, Calif., Oct. 01, 2026 (GLOBE NEWSWIRE) -- BioCardia(®), Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported it has completed its revised Pre-Submission to FDA Center for Devices and Radiological Health (CDRH) under its Q-Submission program for the approval of its Helix Catheter (“Helix”) for therapeutic and diagnostic agent delivery to the heart.
In May 2026, the Company and FDA met and reviewed our initial DeNovo pre-submission. FDA agreed that there are two pathways for Helix marketing clearance and raised no concerns regarding the Helix safety data, device performance, or compatibility with general classes of agents. In August 2026, the FDA confirmed and accepted the meeting minutes as summarized by BioCardia. The revised De Novo pre-submission for the Helix catheter incorporates the advice from FDA CDRH detailed in the minutes.
Get started
Create a free account to read the full story.