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Inspira Technologies has received FDA 510(k) clearance for its INSPIRA ART100 system—a cardiopulmonary bypass device now being deployed in U.S. hospitals. The company’s AI-powered HYLA blood sensor demonstrated 96% accuracy compared to standard analyzers in a clinical study at Sheba Medical Center. The next-generation INSPIRA ART500 remains under development with plans for further clinical studies and regulatory submissions in 2025.
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