BioCardia confirms Q4 2026 PMDA Shonin submission plans, Helix De Novo pre-submission to FDA

BioCardia confirmed Q4 2026 timing for a PMDA Shonin submission for CardiAMP and plans a De Novo pre-submission to the FDA for Helix this quarter.Key Highlights:Original SEC Filing: BioCardia, Inc. [ BCDA ] - 8-K - Sep. 23, 2026This is an AI-powered summary. It may contain inaccuracies. Consider ve…