Last month, Inspira had applied for approval for its INSPIRA ART100 device from the Israeli Government’s Ministry of Health medical device regulation unit. Credit: Shutterstock / Iryna Inshyna.

Israeli respiratory medical device company Inspira Technologies has announced the launch of a programme designed to explore the use of its INSPIRA ART100 device, an artificial womb for newborn children needing respiratory support.

The program is aimed at exploring how the company’s INSPIRA ART100 device could be used in place of traditional mechanical ventilators to overcome some of the adverse effects associated with their use with newborn children.

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Additionally, the programme aims to examine the use of the device with prematurely born neonates, born with underdeveloped respiratory systems, as well as neonates with life-threatening respiratory disorders such as meconium aspiration syndrome.

Inspira Technologies CEO Dagi Ben-Noon said: “This initiative marks another step in the journey towards providing safer alternatives to mechanical ventilation. Together, we are targeting to reshape the landscape of acute neonatal care.”

Last month, Inspira applied for approval for its INSPIRA ART100 device from the Israeli Government’s Ministry of Health medical device regulation unit to eventually make its way into the South American and South-East Asian markets. However, Inspira adds that none of its products have yet been tested or used in humans and have not been approved by any regulatory entity.

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A report by GlobalData estimates the global respiratory devices market will grow to just over $19bn by 2033, up from $12.7bn in 2023. Research carried out by GlobalData in 2023, in the immediate wake of the Covid-19 pandemic, found that whilst the pandemic saw ventilators and other related medical devices in high demand, that growth has since levelled out.

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Speaking after the company’s submission to the Israeli health authority, Ben-Noon said: “We are immensely proud to submit our initial blood oxygenation device, the INSPIRA ART100 for AMAR approval, ahead of our INSPIRA ART (Gen 2) device designed to treat patients while awake without the need for mechanical ventilation, marking a pivotal moment in our mission to redefine life support on a global scale.”

Elsewhere in the field of ventilators, the US FDA has officially classified the recall of approximately six million of Vyaire’s respiratory support devices as Class I – the most serious type of recall.