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健世科技-B(09877.HK):旗下產品入選歐洲專家小組科學建議試點項目
阿思達克 10-10 16:37
健世科技-B(09877.HK)公布,繼入選美國食品及藥物管理局的產品全生命週期諮詢計劃試點後,LuxValvePlus(經頸靜脈三尖瓣置換產品)入選專家小組科學建議試點項目。 歐洲藥品管理局發起的專家小組科學建議試點項目,旨在就若干高風險醫療器械的預期臨床開發策略及臨床研究提議提供科學建議,並促進加快以創新方式為患者提供更安全及高效的器械。 健世科技指,專家小組將就Lux-ValvePlus的臨床開發策略及或臨床研究向公司提供建議,預期將會加快Lux-ValvePlus有關於歐洲獲得CE認證的臨床開發及註冊進度。
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