Northwestern Memorial Hospital in Chicago, US, has signed a non-binding LOI with Israel-based medical device company Inspira Technologies to explore the clinical application of the INSPIRA ART100 device.
In September 2023, Inspira Technologies sought 510(k) clearance from the US Food & Drug Administration (FDA) for INSPIRA ART100, which is a cardio-pulmonary bypass device.
The FDA clearance is anticipated in the first half of 2024.
Through this device, Inspira aims to provide an alternative to traditional mechanical ventilators, to more than 20 million patients annually.
The Northwestern Memorial Hospital is a part of Northwestern Medicine, which operates many hospitals in the US.
The LOI indicates the interest shown by the hospital in exploring the alignment of the INSPIRA ART100 device with its clinical requirements, and enhancing workflow efficiency and healthcare delivery, claimed the Israeli company.
Northwestern will also agree to procure all necessary disposables for the operation of the device, and also provide Inspira Technologies with crucial data and device diagnostics derived from practical usage.
The terms specified in the LOI are contingent on the FDA granting clearance for the device in the first half of 2024, as well as a definitive evaluation agreement.
Inspira Technologies president Joe Hayon said: “We believe that an opportunity to evaluate the INSPIRA ART100 with a leading hospital, such as Northwestern, may evolve into a significant route to entering the healthcare market in the US.”
The company is focused on advancing blood circulation technology and incorporating AI-driven monitoring systems that would enable hospitals to provide patient-focused, and data-informed respiratory care.