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BioCardia (BCDA) Says Ongoing HF II Trial May Be Sufficient for FDA Approval
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BioCardia announced the CardiAMP HF II trial design and said FDA recently agreed the ongoing study may be sufficient to support approval. The poster will be presented at HFSA 2026. Material Details #DetailAI Analyst View1FDA: trial may support approvalSignals a potentially pivotal path to market; reduces regulatory risk if outcomes are positive.2CardiAMP HF II trial ongoingConfirms active pivotal-like study for HFrEF; timing and readouts can be catalysts.3Poster at HFSA…