NEWS
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 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.
The 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.
The 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.
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