The system is used in extra-corporeal membrane oxygenation and cardiopulmonary bypass procedures. Credit: Svitlana Hulko / Shutterstock.

Inspira Technologies OXY has announced the receipt of the Israeli Ministry of Health’s approval for its INSPIRA ART100 system, marking a significant step in the company’s efforts to commercialise its medical technology.

The approval from the Israeli Ministry of Health’s medical devices and accessories (AMAR) division is for the system’s use in extra-corporeal membrane oxygenation and cardiopulmonary bypass procedures.

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The Israeli regulatory approval is a pivotal achievement for Inspira Technologies, as it underpins the company’s strategy to initiate business development activities to introduce its innovative products to the market.

The endorsement by the Israeli Ministry of Health is seen as a testament to Inspira’s ability to navigate the regulatory landscape and secure approvals for its medical devices.

Inspira medical director Dr Dekel Stavi said: “As a physician and the head of the Israeli ECMO Society, I am delighted to witness this exciting milestone where hospitals will have the opportunity to acquire and use the innovative and technologically cutting-edge INSPIRA ART100.”

Inspira Technologies CEO Dagi Ben-Noon said: “After we received FDA approval for the INSPIRA ART100 that will allow us to establish our presence in the US, receiving AMAR approval will facilitate the creation of business opportunities in new regions and emerging markets.”

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Inspira Technologies has previously secured the US Food and Drug Administration (FDA) 510(k) clearance for the INSPIRA ART100 system for cardiopulmonary bypass procedures. The AMAR certification extends this approval for extra-corporeal membrane oxygenation.

While the INSPIRA ART100 system has reached regulatory milestones, the company’s other products, such as the INSPIRA ART (Gen 2) and the HYLA blood sensor, are still in development.