创新医疗器械特别审查申请审查结果公示（2025年第3号）
发布时间：2025-03-26
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2025年3月26日至4月10日。
1.产品名称：人类3号和10号染色体异常细胞检测试剂盒（荧光原位杂交法）
申 请 人：珠海圣美生物诊断技术有限公司
2.产品名称：生物疝修补补片
申 请 人：卓阮医疗科技（苏州）有限公司
3.产品名称：一次性使用心腔内超声成像导管
申 请 人：上海微创电生理医疗科技股份有限公司
4.产品名称：磁控无创可延长假体系统
申 请 人：北京爱康宜诚医疗器材有限公司
5.产品名称：抗栓塞脑保护装置
申 请 人：上海申淇医疗科技有限公司
6.产品名称：青光眼引流管
申 请 人：明澈生物科技（苏州）有限公司
7.产品名称：麻风分枝杆菌核酸检测试剂盒（荧光PCR法）
申 请 人：苏州方科生物科技有限公司
8.产品名称：质子治疗系统
申 请 人：瓦里安医疗系统粒子治疗有限公司
9.产品名称：肾动脉超声消融仪
申 请 人：上海汉通医疗科技有限公司
10.产品名称：植入式神经刺激系统
申 请 人：博睿康医疗科技（上海）有限公司
11.产品名称：冠状动脉介入手术控制系统
申 请 人：北京中科鸿泰医疗科技有限公司
12.产品名称：新生儿TREC/KREC基因检测试剂盒（荧光PCR法）
申 请 人：上海捷易生物科技有限公司
13.产品名称：结直肠癌数字病理图像微卫星不稳定性分析软件
申 请 人：苏州可帮基因科技有限公司
14.产品名称：可降解镁合金接骨螺钉
申 请 人：华融科创生物科技（天津）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
2025年3月26日
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