智通财经APP获悉，先健科技(01302)盘中涨超9%，截至发稿，涨7.28%，报1.62港元，成交额3223.94万港元。
消息面上，先健科技公告，公司自主研发的LAmbre Plus左心耳封堵系统的一项由FDA批准的上市前临床试验获得美国医保覆盖。该试验为一项前瞻性、多中心、随机对照研究，并计划于不超过75家美国研究中心有偿植入LAmbre Plus。在达到既定的临床里程碑后，公司将向美国食品药品监督管理局（FDA）递交产品上市申请。
据悉，公司自主研发的LAmbre Plus是在LAmbre左心耳封堵系统的基础上进一步结构优化的产品。LAmbre在产品设计及技术上均具行业先进性，其目前已在全球近四十个国家累计临床应用近四万例。公司有信心该器械在完成美国上市前临床研究后，顺利获得美国FDA的上市批准。
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