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BCDA

BioCardia, Inc. Common Stock

BCDAStockUnited States

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45Impact
Neutral1 Oct 2026 · 13:15 UTC · Global · Medium term
BioCardia files revised De Novo pre-submission for Helix catheter FDA approval
BioCardia (BCDA) submitted a revised Q-Submission to FDA's CDRH for its Helix catheter, a device for therapeutic and diagnostic agent delivery to the heart. The revised filing follows earlier pre-submission feedback and positions the company for potential De Novo classification pathway.
BCDAMedical DevicesCardiovascularBiotechnology

SEC filings

What BCDA filed

All its filings

6 Nov 2026
Other event (opens the document on sec.gov)8-K
19 Oct 2026
Other event (opens the document on sec.gov)8-K
7 Oct 2026
Other event (opens the document on sec.gov)8-K
1 Oct 2026
Other event (opens the document on sec.gov)8-K
23 Sept 2026
Other event (opens the document on sec.gov)8-K
21 Sept 2026
Other event (opens the document on sec.gov)8-K
10 Sept 2026
Other event (opens the document on sec.gov)8-K
24 Aug 2026
Investor communication (opens the document on sec.gov)8-K
21 Aug 2026
Listing notice (opens the document on sec.gov)8-K
12 Aug 2026
Results announced (opens the document on sec.gov)8-K
12 Aug 2026
Quarterly report (opens the document on sec.gov)10-Q
18 Jun 2026
Investor communication (opens the document on sec.gov)8-K
12 Jun 2026
Listing notice (opens the document on sec.gov)8-K
8 Jun 2026
Other event (opens the document on sec.gov)8-K
5 Jun 2026
Investor communication (opens the document on sec.gov)8-K

From SEC EDGAR, the public record of what US-listed companies file. Each document opens on sec.gov.

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Latest news on BCDAranked by Oyticker for market impact

BioCardia files revised De Novo pre-submission for Helix catheter FDA approval

What BCDA filed