Inspira Technologies Nears Final Regulatory Clearance for the ART100 in the UAE, Accelerating Gulf Region Expansion

Core Insights - Inspira Technologies has completed the regulatory submission of its FDA-cleared INSPIRA™ ART100 system to the UAE Ministry of Health and Prevention, with final approval expected imminently, marking a significant step towards commercial entry into the Gulf region [1][2][3] Company Overview - Inspira Technologies is a commercial-stage medical device company specializing in advanced respiratory support and real-time blood monitoring solutions, with the INSPIRA™ ART100 system approved for cardiopulmonary bypass in the U.S. and ECMO procedures outside the U.S. [4] - The company is also developing the INSPIRA ART500, a next-generation system designed for oxygenation while patients remain awake and spontaneously breathing, alongside advancing the HYLA™ blood sensor platform for continuous, non-invasive monitoring [4] Regulatory and Market Strategy - The regulatory milestone follows high-level discussions in the UAE, laying the groundwork for potential nationwide deployment and clinical integration of the ART100 system post-approval [2][3] - The UAE is recognized for its efficient and innovation-driven regulatory framework, which is expected to enhance Inspira's regional partnerships and unlock broad commercialization potential across the UAE's healthcare networks [3]