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BioCardia, Inc.
BioCardia, Inc. insider Peter Altman reported a change in beneficial ownership of securities as of October 15, 2026. This Form 4 filing details the insider's transaction and does not involve new share issuance or capital raising activities that would impact the company's financial structure.…more
BioCardia, Inc.
BioCardia announced that the FDA has accepted its De Novo pre-submission package for the marketing clearance of its Helix catheter. The company expects to undergo substantive FDA review and hold a meeting within this quarter to advance the approval process.…more
BioCardia, Inc.
BioCardia is presenting the design and scientific rationale for its CardiAMP HF II clinical trial at the Heart Failure Society of America (HFSA) Annual Scientific Meeting. The company noted that the FDA has indicated the ongoing CardiAMP HF II trial may be sufficient to support future regulatory approval.…more
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BioCardia Receives FDA Acceptance For Helix Catheter Pre-Submission
BioCardia has received FDA acceptance for its pre-submission package regarding the marketing clearance of the Helix catheter. While this marks progress toward commercialization, further regulatory steps are required before the product can generate revenue.…more
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BioCardia is presenting the clinical trial design and scientific support for its CardiAMP HF II therapy at the Heart Failure Society of America meeting. The company is currently advancing the trial to support potential FDA approval, though no final results have been confirmed.…more
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BioCardia has completed its revised pre-submission to the FDA for the approval of its Helix Catheter, designed for cardiac therapeutic and diagnostic delivery. This regulatory step marks progress in the company's efforts to bring its medical device to market.…more
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