BioCardia与日本药品医疗器械综合机构(PMDA)已就Cardiamp疗法临床数据的可接受性达成一致,该数据将用于支持其在缺血性心力衰竭适应症上的监管批准申请。此次共识标志着该疗法在进军日本监管审批流程中迈出了关键一步。
BioCardia与日本药品医疗器械综合机构(PMDA)已就Cardiamp疗法临床数据的可接受性达成一致,该数据将用于支持其在缺血性心力衰竭适应症上的监管批准申请。此次共识标志着该疗法在进军日本监管审批流程中迈出了关键一步。
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