BioCardia submits revised FDA pre-submission for Helix catheter
The company reported on October 1, 2026 that it filed an updated De Novo pre-submission with FDA's device center for its Helix catheter.
SEC filing
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Today
Thursday, September 10
BioCardia to present CardiAMP and Helix updates at H.C. Wainwright conference
CEO Peter Altman will detail regulatory progress in Japan and the US and pipeline milestones at the September conference in New York.
SEC filing
Monday, August 24
BioCardia says FDA finalized minutes on Helix catheter pre-submission meeting
The company said it plans to file a follow-on pre-submission this quarter, aiming toward a possible De Novo approval pathway for its Helix delivery catheter.
SEC filing
Wednesday, August 12
BioCardia gets positive regulator signals in Japan and US for CardiAMP and Helix
PMDA and FDA feedback support advancing both a Japan filing this year and the ongoing US pivotal trial, while cash stood at $4.1 million with runway into 2027.
SEC filing