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樂心醫療(300562.SZ):臂式電子血壓計產品的認證申請已獲FDA受理
格隆匯 09-29 19:41

格隆匯 9 月 29日丨樂心醫療(300562.SZ)公佈,公司於近日收到美國FDA下發的《Acknowledgment Letter》,獲知公司的臂式電子血壓計產品的認證申請已獲FDA受理。

臂式電子血壓計外觀上採取單按鍵設計,外觀設計簡約、大方。血壓計採用示波法通過袖帶傳感器取得的壓力和脈搏信號來自動完成間接測量(無創)動脈血壓的裝置。血壓計內置物聯網SIM卡,無需WIFI、無需數據線,測試結果通過蜂窩網絡實時傳輸到手機APP上。血壓計主機結構包括氣泵、壓力傳感器、放氣閥、電源供應電路、按鍵控制電路、CPU控制模塊、嵌入式軟件。產品的關鍵部件為:壓力傳感器、袖帶、嵌入式軟件(用於血壓監測過程控制、信號特徵提取以及血壓的計算)。

臂式電子血壓計產品目前所處的審批階段為認證申請受理,後續所需的審批流程為技術審評、發行summary。上述產品認證申請受理對公司近期業績不會產生影響,審評在各階段所需的時間和結果均具有一定的不確定性,因此,公司尚無法預測其對公司未來業績的影響,公司將根據此次認證的進展情況及時履行信息披露義務。

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