启明医疗(02500.HK)经导管人工肺动脉瓣膜系统获英国特殊使用许可
启明医疗(02500.HK)公布,核心产品经导管人工肺动脉瓣膜系统VenusP-Valve已获得英国药品监管局特殊使用许可,可在指定医疗机构进行使用。
公司表示,特殊使用许可适用於临床急需且尚未有同类产品上市的医疗产品,VenusP-Valve已於2019年在欧洲申报CE认证,目前处於审评阶段,此次特殊使用许可意味着VenusP-Valve在尚未获得CE认证的情况下,可以提前进入英国市场。
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