BioCardia files revised FDA pre-submission for Helix catheter
BioCardia filed a revised De Novo pre-submission with the FDA for its Helix catheter.
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01:23:18 PM UTC
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BioCardia completed a revised Pre-Submission to FDA CDRH for De Novo approval of its Helix catheter.Key Highlights:Original SEC Filing: BioCardia, Inc. [ BCDA ] - 8-K - Oct. 01, 2026This is an AI-powered summary. It may contain inaccuracies. Consider verifying important information with the source…