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Inspira Technologies Announces Has FDA Class I 510(k) Exempt component Of The ART System

Inspira Technologies Announces Has FDA Class I 510(k) Exempt component Of The ART System

Inspira技术公司宣布在ART系统中拥有FDA I类510(K)豁免组件
Benzinga Real-time News ·  2022/01/28 09:10

Inspira Technologies OXY B.H.N. Ltd. (NASDAQ:IINN) (NASDAQ:IINNW) (the "Company" or "Inspira Technologies"), a groundbreaking respiratory support technology company, announced today that has listed a component of its ART and ECLS systems on the U.S. Food and Drug Administration Class I 510(k) exempt list.

Inspira Technologies Oxy B.H.N.Ltd.(Inspira Technologies Oxy B.H.N.Ltd.)纳斯达克(纳斯达克股票代码：IINNW)(以下称“公司”或“Inspira Technologies”)，一家具有开创性的呼吸支持技术公司今天宣布，已将其ART和ECLS系统的一个组件列入美国食品和药物管理局I类510(K)豁免名单。

The component is intended to reduce the potential complications associated with jugular vein cannula movement, occurring during a change of a patient's posture in bed and/or during transportation.  The component can also be potentially utilized in the treatment of thousands of patients being treated each year by Extracorporeal Membrane Oxygenation (ECMO). This component is expected to allow the medical staff a safer mobilization for the awake cannulated patients within and between hospitals and medical centers.

该部件旨在减少与颈静脉插管运动相关的潜在并发症，这种并发症发生在患者在床上和/或在运输过程中改变体位的过程中。该成分还可以潜在地用于治疗每年接受体外膜氧合(ECMO)治疗的数千名患者。这一组成部分预计将允许医务人员在医院和医疗中心内和医院之间更安全地动员清醒的插管病人。

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