BioCardia Submits Revised FDA Pre-Submission for Helix Catheter Approval
BioCardia filed a revised Pre-Submission with FDA's CDRH seeking De Novo approval for its Helix Catheter, designed for cardiac agent delivery.
BioCardia, Inc. (Nasdaq: BCDA) announced Thursday it has completed a revised Pre-Submission to the U.S. Food and Drug Administration's Center for Devices and Radiological Health, advancing its bid for regulatory approval of the Helix Catheter under the agency's Q-Submission program.
The Sunnyvale, California-based company is seeking De Novo classification for the Helix, a device engineered to deliver therapeutic and diagnostic agents directly to the heart. The De Novo pathway is typically used for novel, low-to-moderate risk medical devices that lack a legally marketed predicate, making it a critical regulatory route for first-of-kind cardiovascular tools.
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BioCardia describes itself as a global leader in cellular and cell-derived therapeutics targeting cardiovascular and pulmonary diseases. The Helix Catheter represents a key platform asset in its pipeline, intended to enable precise intracardiac delivery that could support a range of future cell therapy and diagnostic applications.
The revised submission signals the company has responded to prior FDA feedback, a standard step in the iterative Q-Submission process designed to align sponsors with agency expectations before a formal application is filed. The outcome of FDA's review of the revised pre-submission could shape the timeline for any subsequent De Novo request.
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