Inspira™ Technologies Announces FDA Listing and Market Readiness of New Product

Core Viewpoint - Inspira Technologies has received FDA listing for its INSPIRA™ CART, designed to enhance the INSPIRA™ ART100 system, aiming to improve healthcare delivery in various clinical settings [1][2]. Company Overview - Inspira Technologies focuses on life-support technology innovation, targeting a combined market opportunity of approximately $59 billion annually through its advanced blood oxygenation and monitoring technologies [3]. Product Development - The INSPIRA™ CART is classified as a Class I Medical Device and is 510(K) Exempt, facilitating its entry into the U.S. market for use in cardiopulmonary bypass procedures [2][7]. - The company is developing several products, including the HYLA™ blood sensor for continuous blood parameter monitoring and the INSPIRA™ Cardi-ART, a portable unit for brain oxygenation during cardiac arrest [4][5][6]. Regulatory Status - The INSPIRA™ ART100 system has received FDA 510(k) clearance for cardiopulmonary bypass procedures and AMAR certification for extra-corporeal membrane oxygenation [7].