Business
Inspira™ Technologies Announces FDA Listing and Market Readiness of New Product
RA'ANANA, Israel, Aug. 22, 2024 /PRNewswire/ -- Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) ("Inspira" or the "Company"), a leader in
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[{"type":"text","content":"RA'ANANA, Israel, Aug. 22, 2024 /PRNewswire/ -- Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (\"Inspira\" or the \"Company\"), a leader in life-support technology innovation, today announces the U.S. Food and Drug Administration (\"FDA\") listing of its medical cart (INSPIRA™ CART) which has been custom designed for use with the INSPIRA™ ART100 system. With this dynamic combination of cutting-edge technology and operational efficiency, Inspira aims to streamline healthcare delivery in a variety of clinical scenarios, transforming the INSPIRA™ ART100 system into a mobile workstation supporting medical personnel in administering medical care quickly.\n\nThe INSPIRA™ CART is intended for use by medical professionals in operating rooms in the United States during Cardiopulmonary Bypass procedures. Classified as a Class I Medical Device and 510(K) Exempt under the FDA code for cardiopulmonary bypass accessory equipment, this device's regulatory status underscores its compliance with safety and efficacy standards, facilitating its entry into the U.S. market.\nDagi Ben-Noon, CEO of Inspira, commented, \"We believe that the ongoing progress and pipeline of products of the Company will potentially translate in the future into substantial recognition by strategic partners and investors, with the Company already receiving first order of INSPIRA™ CARTs from Glo-Med Networks, Inc.\"\nInspira™ business overview\nInspira aims to reshape the respiratory and life-support landscape. We are developing novel life support-extending technologies with Inspira blood oxygenation and blood monitoring technologies, collectively targeting an estimated combined market opportunity of approximately $59 billion a year.\nInspira is working to deploy the FDA cleared INSPIRA™ ART100 system in leading U.S and Israeli hospitals. The Company's overall strategy is to generate business development activities with potential partners who are aiming to expand their product portfolio in the industry.\nInspira continues to grow and pioneer the INSPIRA™ ART pipeline, including:\nHYLA™ blood sensor- being designed to monitor blood parameters continuously and in real-time.\nINSPIRA™ Cardi-ART- a portable unit, derived from the INSPIRA™ ART (Gen 2) product, is being designed to oxygenate the brain to support patients undergoing cardiac arrest.\nINSPIRA™ ...