BioCardia: FDA accepts De Novo pre-submission for Helix catheter

What happened The filing says that on Oct 19, 2026 BioCardia, Inc. issued a press release announcing FDA acceptance of a De Novo pre-submission package for the Helix catheter. The press release says a substantive review and a meeting with the FDA are expected this quarter.

Key details

• Date of press release: Oct 19, 2026.
• Subject: FDA acceptance of a De Novo pre-submission package for the Helix catheter.
• The filing says FDA substantive review and a meeting are expected this quarter.
• The press release is attached as Exhibit 99.1 to the Form 8-K.

Why it may matter This Form 8-K reports Item 8.01 (Other events), which covers events the company elects to disclose outside other specified Form 8-K items and furnishes the press release about FDA acceptance of a De Novo pre-submission package for the Helix catheter. A filing does not show why the insider traded or why the company acted.