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永勝醫療(01612.HK):inspired™ VHB20加熱式加濕器通過FDA 510(k)許可
格隆匯 01-03 16:36

格隆匯1月3日丨永勝醫療(01612.HK)宣佈,集團最近就其inspired VHB20加熱式加濕器("加濕器")通過美國食品藥品監督管理局("FDA")的510(k)許可。

加濕器為inspired品牌首個通過FDA510(k)許可的電子器械。此器械為一種呼吸機用加濕器,其發熱及温度控制功能將冰冷而且乾燥的醫療氣體進行適當的加熱及濕化。已加熱及濕化的醫療氣體其後輸送到需要機械通氣或正壓呼吸協助之病人。加濕器為主動加濕系統,可按照醫護人員所選的設置自動維持氣體的温度及相對濕度,可適合醫院內的嬰兒至成人病人使用。當完成每個病人的治療程序並更換耗材後,加濕器可供多名病人作治療用途。

較早前於2022年10月,在第35屆歐洲重症監護醫學會年度大會上,魁北克大學心臟病學及肺病學研究所重症監護專科醫生兼拉瓦爾大學醫學院副教授François Lellouche博士以海報研討會形式發表之評監報吿中指出,根據在專業實驗室進行的基準測試初步數據顯示,加濕器的加濕性能優於在該評估中使用的其他可相比之同類型加熱式加濕器。

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