创新医疗器械特别审查申请审查结果公示（2024年第10号）20241114
发布时间：2024-11-14
依据国家药品监督管理局《创新医疗器械特别审查程序》（国家药监局2018年第83号公告），创新医疗器械审查办公室组织有关专家对创新医疗器械特别审查申请进行审查，拟同意以下申请项目进入特别审查程序，现予以公示。公示时间为2024年11月14日至11月28日。
1.产品名称：血管内超声诊断系统
申 请 人：深圳皓影医疗科技有限公司
2.产品名称：脉冲电场消融设备
申 请 人：上海澍能医疗科技有限公司
3.产品名称：磁定位多通道脉冲电场射频消融系统
申 请 人：伯恩森斯韦伯斯特（以色列）有限责任公司
4.产品名称：EGFR/KRAS/MET基因突变检测试剂盒(可逆末端终止测序法)
申 请 人：南京世和医疗器械有限公司
5.产品名称：可生物降解胆道和胰管支架
申 请 人：amg国际有限公司
6.产品名称：外周血管慢性闭塞病变旋通装置
申 请 人：阿维格公司
7.产品名称：植入式心室辅助系统
申 请 人：深圳核心医疗科技股份有限公司
8.产品名称：紫杉醇药物涂层颅内球囊扩张导管
申 请 人：贝朗医疗（苏州）有限公司
9.产品名称：质子治疗系统
申 请 人：合肥中科离子医学技术装备有限公司
公示期内，任何单位和个人如有异议，可书面提交异议意见，发送至我中心电子邮箱：gcdivision@cmde.org.cn。
特别说明：进入创新审查程序不代表已认定产品具备可获准注册的安全有效性，申请人仍需按照有关要求开展研发及提出注册申请，药品监督管理部门及相关技术机构将按照早期介入、专人负责、科学审查的原则，在标准不降低、程序不减少的前提下进行审评审批。
国家药品监督管理局
医疗器械技术审评中心
2024年11月14日
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