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祥生醫療(688358.SH):SonoEye系列掌上超聲產品正式獲美國市場準入許可
格隆匯 02-26 16:51

格隆匯 2 月 26日丨祥生醫療(688358.SH)公佈,公司於近日獲得美國食品藥品監督管理局(FDA)的通知,公司SonoEye系列掌上超聲產品正式獲得美國市場準入許可。

隨着便攜超聲產品在醫學診斷領域應用的不斷擴展,芯片小型化技術、低功耗技術的日趨成熟,臨牀應用對超聲設備的便攜性、小型化提出了更高要求,掌上超聲作為新型的便攜小型化超聲產品,應用已涉及重症監護、急診、麻醉、婦產等科室,成為醫用診斷的重要設備之一,也是全球醫療器械產業中增長較快的產品類型之一。

公司SonoEye系列掌上超聲產品迄今為止公司便攜小型化產品中重量最輕、體積最小的超聲產品。此次SonoEye系列產品取FDA 市場準入許可,標志着相關產品獲得了進入美國市場銷售的資質,可以在美國及相關海外市場銷有利於進一步提高公司在便攜小型化和專科超聲診斷領域的市場競爭力,對於公司產品在海外市場的推廣和銷售將起到積極推動作用。

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