BioCardia Says FDA Finalized Pre-Submission Meeting Minutes For Helix Transendocardial Delivery Catheter; Plans Follow-On Pre-Submission This Quarter Toward Potential De Novo Approval
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Why It Matters
BioCardia finished talking with the FDA (government) about their heart catheter device, and the FDA wrote down what they discussed. The company is planning more meetings this quarter, which suggests the FDA process is moving forward—a sign they're on track to get approval.
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Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.
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