智通财经APP获悉，堃博医疗-B(02216)涨近10%，截至发稿，涨9.96%，报2.65港元，成交额329.29万港元。
消息面上，1月12日晚，堃博医疗发布公告称，旗下BroncTarget®肺部靶向去神经射频消融系统(简称“BroncTarget®系统”)正式进入中国国家药品监督管理局的创新医疗器械特别审查程序(国家药监局公示文件中披露产品名为：“肺部射频消融系统”)，标志着该产品在核心技术原创性、临床价值显著性等方面获得国家药监部门的认可。目前，BroncTarget®系统的确证性临床试验正在有序开展中，全国28家医院正同步推进受试者招募。
此外，据堃博医疗公众号披露，近日，其自主研发的BroncAblate®智衡®肺部射频消融系统正式获得香港卫生署医疗器械表列（注册批准），标志着这款全球首款经自然腔道射频消融肺癌介入治疗器械在香港正式商业化落地。同期，FleXNeedleCN一次性内窥镜吸引活检针亦取得香港卫生署医疗器械表列（注册批准）。此外，途扩®BroncTru® 一次性使用经支气管镜扩张导管成功获得印尼卫生部批准，正式进入印尼市场，实现东南亚市场新突破。
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