摘要:Sanuwave公司近日宣布,美国食品和药物管理局(FDA)已经批准了其体外冲击波治疗设备Dermapace系统用于糖尿病足溃疡创面的治疗,这也是第一个被批准用于慢性创面治疗的ESWT设备。此项新适应证的批准是基于两项设计规范的临床多中心、双盲、随机对照(RCT)研究。
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