Inspira Technologies (IINN) announced positive results from the clinical study of its AI-powered HYLA blood sensor. The HYLA achieved 96% accuracy in its clinical study results for a key parameter, as compared to traditional blood test analyzers. In addition, the study was utilized for testing new parameters including a new indicator for identifying oxygen deficiencies, demonstrating 92.3% accuracy. This real-time continuous measurement capability may help prevent blood oxygen deficiency during surgical procedures without the need for blood draws. The clinical study involved 6 patients undergoing open-heart surgery. With this clinical study being utilized to focus on accuracy testing against current hospital blood lab testing methods, the Company plans to advance the study to collect additional patient data to further expand the system’s AI-powered learning capabilities, towards early detection diagnostics software development. The company anticipates that these new results will support the advancement towards its expected FDA submission of the first HYLA configuration in the second half of 2025. Once FDA clearance is obtained, the company plans to deploy this core technology of the INSPIRA ART in U.S. hospitals for data collection and post-market validation.
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