Inspira™ Announces 510(k) FDA Submission of INSPIRA™ ART100 Towards Commercialization

Management estimates FDA clearance within approximately 6 months

RA'ANANA, Israel, Sept. 13, 2023 /PRNewswire/ -- Inspira™ Technologies OXY BHN Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira Technologies"), a company aiming to bring a paradigm shift to acute respiratory care by empowering breathing without lungs, announced it had submitted its INSPIRA ART 100, a cardio-pulmonary bypass device, to the U.S. Food and Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024.