BioCardia Submits Revised FDA Pre-Submission for Helix Catheter Approval
BioCardia filed a revised Pre-Submission to the FDA's CDRH seeking approval of its Helix Catheter 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 under the agency's Q-Submission program, advancing its bid to win regulatory clearance for the Helix Catheter.
The Sunnyvale, California-based company is seeking approval of the Helix for both therapeutic and diagnostic agent delivery to the heart. The filing represents a revised iteration of an earlier submission, signaling continued back-and-forth engagement with the FDA as the company works through the De Novo pathway — a route typically used for novel, low-to-moderate-risk medical devices without a legally marketed predicate.
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BioCardia positions itself as a global developer of cellular and cell-derived therapeutics targeting cardiovascular and pulmonary diseases. The Helix Catheter is a core delivery platform within that pipeline, designed to transport agents directly to cardiac tissue — a capability that would underpin multiple potential future therapies.
The De Novo pathway, administered by CDRH, grants marketing authorization and can establish a new regulatory classification, potentially opening the door for future devices to cite the Helix as a predicate. Successful FDA clearance would mark a significant commercial milestone for the company. No timeline for an FDA response was disclosed in the announcement.
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