
温州睛睿之元科技有限公司获三类医疗器械注册证,实现从实验室到手术室的创新转化
国家药监局批准温州睛睿之元科技有限公司的耳鼻喉科手术导航设备上市。该设备由温州医科大学吴文灿教授团队研发,定位精度达0.12毫米,标志着中国眼谷小镇在眼健康产业创新链条上的重要成果转化。
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中国眼谷小镇位于温州环大罗山科创走廊,由龙湾区政府与温州医科大学附属眼视光医院共建。该平台旨在通过临床需求驱动,打通从基础研究到产业落地的全链路。
中新网温州11月14日电(张益聪)在眼眶、鼻腔与颅底交错的毫米级术野里做微创手术,好比在层叠交错的立交桥缝隙间精准穿行,毫厘偏差便可能触碰神经与血管的“安全红线”。
近日,国家药监局批准中国眼谷小镇入驻企业温州睛睿之元科技有限公司的耳鼻喉科手术导航设备上市。透过这张三类医疗器械注册证,从中可以看见,在中国眼谷小镇科创平台驱动下,临床需求如何牵引技术研发、工程算法如何迭代产品形态、产业平台如何承接成果转化,一条“从实验室到手术室”的全链条创新生态清晰浮现。
技术纵深:在毫米“禁区”看得见、定得准
这款导航设备的技术根脉,源于临床一线的真实痛点。温州医科大学吴文灿教授团队长期深耕视神经疾病、眼鼻相关疾病的内镜微创诊疗,在眶尖区域手术中始终面临一道核心难题:此处解剖结构层叠密集,视神经等超微结构难以精准定位,术中高清可视化不足,一直是外科手术的高风险“禁区”。
据介绍,围绕眶尖视神经微创手术的精准定位需求,上述团队自主研发视神经专用三维颅底导航技术,将定位精度提升至0.12毫米,为破解这一临床难题提供了核心技术支撑。
此次获批的导航设备,正是该技术的产业化落地成果,覆盖眼鼻、颅面相关外科手术场景,通过光学导航引导与术中实时跟踪,为术者提供精准的操作指引与安全边界保障。相较于通用导航设备,该系统针对亚洲人群颅面解剖特征完成了专属算法优化,支持个性化手术路径规划;同时集成AR增强现实功能,可将多层医学影像叠加呈现,让医生在微小微创切口下获得近似“透视”的导航效果,实现从“指得准”到“看得清、规划细”的能力升级。
转化机制:从临床问题到成果落地打通路径
聚焦成果转化,承接上述技术产业化的企业,于2023年落户温州市龙湾区中国眼谷小镇,专注于眼科数字诊疗系列装备的研发、生产与销售。这并非吴文灿团队与中国眼谷的首次“牵手”——此前,该团队研发的视神经生物微管等成果,已通过校地成果转化平台落地中国眼谷,实现从科研到产业的跨越。
从临床诊疗中凝练科研方向,再通过导航装备、内镜技术、生物材料等产品矩阵推动产业化,中国眼谷小镇正在构建“基础研究—临床验证—成果转化—产业落地”的完整创新链路。这款导航设备的获批,正是这条链路上的典型节点:临床团队提出真问题,工程团队把临床经验转化为标准化产品,产业平台承接注册申报与落地配套,进而让实验室技术真正走进临床手术室。
生态支撑:产业平台筑牢创新成长沃土
一款三类医疗器械的快速获批,背后离不开产业生态的全方位支撑。坐落于温州环大罗山科创走廊核心区的中国眼谷小镇,由龙湾区人民政府与温州医科大学附属眼视光医院联合共建,成为孕育该技术产品的核心产业平台。
依托高校的临床、科研、人才资源,叠加地方政府的产业政策与空间配套,中国眼谷小镇聚焦眼科装备、视觉光学、眼用材料、眼科新药、眼科医疗、未来视觉科技等多条赛道,持续集聚企业与创新项目,构建起全周期的产业服务体系。公开数据显示,目前眼谷小镇入驻企业总数已超950家,形成了国内颇具辨识度的眼健康产业集群。
从单点技术突破到全链条生态成型,这款导航设备的落地,是温州眼健康产业创新模式的一次生动印证。未来,中国眼谷小镇将以科技创新为导向,产出更多原创性高端诊疗装备,让更精准、更微创、更安全的眼健康技术惠及广大患者。

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