Inspira Technologies Gets Israeli Ministry Of Health Approval For INSPIRA ART100 ECMO System
2024-07-11
2605
(fxcue news) - Israeli medical technology company Inspira Technologies OXY B.H.N. Ltd. (IINN) announced Thursday the receipt of the Israeli Ministry of Health's medical devices and accessories (AMAR) approval for the INSPIRA ART100, an Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass system.
This is a pivotal milestone in Inspira's strategy to conduct business development activities to bring its innovative products and technologies to the market.
The Company believes that receiving Israeli regulatory approval marks an important step towards growing local support and adoption for the INSPIRA ART100 and demonstrates Inspira's capabilities in obtaining regulatory approvals for its products.
The Company's INSPIRA ART100 system received FDA 510(k) clearance for Cardiopulmonary Bypass procedures and AMAR certification for Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures.
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