Inspira announces development of new disposable kit with built-in performance monitoring mechanism

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Inspira Technologies announced the development of a new disposable kit for the perfusion market. The innovative disposable kit is being developed as a single-use product designed to identify and alert users on changes in the performance of the disposable during operation and treatment. The unique design and features of the disposable are expected to provide a smart, compatible, and adjustable experience for medical teams. This is intended to enhance product safety and improve patient protection. 

The disposable kit will be the subject of a planned application for U.S. Food and Drug Administration (FDA) clearance for marketing. Once cleared for marketing, the disposable is expected to be offered to hospitals that use the INSPIRA ART100 system. The INSPIRA ART100 system received FDA 510(k) clearance in May 2024 for Cardiopulmonary Bypass (CPB) procedures and in July 2024 received Israeli medical device and accessory certification for extra-corporeal membrane oxygenation and cardiopulmonary bypass procedures. The first manufactured devices are expected to be deployed in the U.S. by the end of 2024.

Mr. Dagi Ben-Noon, co-founder, and CEO of Inspira Technologies, stated: "This new innovation and capability, being integrated into our disposable kit, is expected to be an additional step by Inspira to provide new technologies and user experiences for the purpose of supporting improved safety and patient care."