---
title: "BioCardia files revised FDA De Novo pre-submission for Helix catheter clearance"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/300689541.md"
description: "BioCardia has submitted a revised De Novo pre-submission to the FDA for marketing clearance of its Helix catheter, designed for heart agent delivery. The FDA previously raised no safety or performance concerns during a May meeting, with minutes accepted in August. The agency targets an initial accept-or-refuse decision within 15 days and written feedback or a meeting within 70 days."
datetime: "2026-10-01T13:15:36.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/300689541.md)
  - [en](https://longbridge.com/en/news/300689541.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/300689541.md)
generator: "portal-rs"
---

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

-   BioCardia filed a revised De Novo pre-submission with the FDA for marketing clearance of its Helix catheter for heart agent delivery. \* FDA previously raised no concerns on safety, performance, or broad agent compatibility in a May meeting; minutes were accepted in August. \* FDA targets an initial accept-or-refuse review within 15 days; written feedback or a meeting within 70 days. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BioCardia Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202610010915PRIMZONEFULLFEED9837659) on October 01, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)

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