Inspira Technologies OXY B.H.N. Ltd. (IINN) recently announced the FDA listing of its INSPIRA CART. This medical cart, designed for use with the INSPIRA ART100 system, aims to enhance healthcare delivery in operating rooms during cardiopulmonary bypass procedures. The FDA classification as a Class I Medical Device and 510(K) Exempt highlights its compliance with rigorous safety and efficacy standards, paving the way for its introduction to the U.S. market. Significance of the Announcement The FDA listing of ...

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 var ...

RA'ANANA, Israel, Aug. 13, 2024 /PRNewswire/ -- Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) ("Inspira," "Inspira Technologies," or the "Company"), a trailblazer in life-support technology, today announced that it was approached by a leading medical technology company in the industry, to evaluate the operation of its proprietary key product in combination with the INSPIRA™ ART100 system. The evaluation was conducted by Inspira researchers. The test results exceeded 100% of the standar ...

RA'ANANA, Israel, July 30, 2024 /PRNewswire/ -- Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company", "Inspira", or "Inspira Technologies"), a trailblazer in life-support technology, proudly introduces the INSPIRA Cardi-ART, a portable modular device, currently in development, to provide oxygen to the brain during cardiac arrest (the "Device" or "INSPIRA Cardi-ART"). Inspira™ Technologies targets to reshape the respiratory and life-support landscape. We are developing novel exp ...

Core Viewpoint - Inspira Technologies OXY B.H.N. Ltd. has received approval from the Israeli Ministry of Health for its INSPIRA™ ART100 system, marking a significant milestone in the company's strategy to expand its market presence and develop innovative medical technologies [1][7]. Group 1: Product Approval and Features - The INSPIRA™ ART100 system is an Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass system that has received both Israeli AMAR approval and FDA 510(k) clearance [9]. - The INSPIRA™ ART (Gen 2), also known as INSPIRA™ ART500, features Adaptive Blood Oxygenation technology, designed to continuously measure blood parameters in real-time and deliver oxygen directly into the bloodstream, potentially allowing patients to remain awake during treatment [2][3]. - The approval of the INSPIRA™ ART100 is expected to facilitate hospitals' acquisition and use of this innovative technology, enhancing patient care [2][7]. Group 2: Strategic Implications - The receipt of Israeli regulatory approval is seen as a crucial step towards increasing local support and adoption of the INSPIRA™ ART100, showcasing the company's ability to secure regulatory approvals [7]. - The CEO of Inspira Technologies emphasized that the AMAR approval will help create business opportunities in new regions and emerging markets, following the earlier FDA approval [8]. - The company aims to reshape the respiratory and life-support landscape by developing novel technologies to prolong and improve the quality of life for patients [8].

Inspira Technologies OXY B.H.N. Ltd. (IINN) disclosed a new business plan with targets for next-generation technologies over a company conference call today. IINN primarily talked about the progress with its core blood oxygenation technology, the INSPIRA ART (Gen 2). The company is also planning to deploy INSPIRA ART100, its cardiopulmonary support device, in the United States and abroad. The INSPIRA ART (Gen 2) device performs direct blood oxygenation, with the patient potentially being awake and without t ...

RA'ANANA, Israel, June 20, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN), (Nasdaq: IINNW) (the "Company" or "Inspira"), a breakthrough medical technology company, announced today that the Company's President and co-founder, Mr. Joe Hayon, presented a business plan with targets for the Company's next-generation technologies on a Company conference call today. Key Highlights from the Presentation: The Company received FDA 510(k) clearance for its INSPIRA ART100, a Cardiopulmonary B ...

RA'ANANA, Israel, June 17, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira Technologies"), a breakthrough medical technology company, is proud to announce today that the Company will present at the annual iECOs Conference in Herzliya, Israel on June 18th, 2024. About iECOs About Inspira Technologies OXY B.H.N. Ltd. The Company received FDA 510(k) clearance for its INSPIRA ART100, a Cardiopulmonary Bypass System. For more information, pleas ...

The planned shipment and potential additional sales of the INSPIRA™ ART100 systems is a pivotal step in the Company's growth model, which is primarily based on the INSPIRA™ ART (Gen 2) that is currently in development and is expected to target the $19 billion mechanical ventilator market, with its next generation cutting-edge technology designed to replace the need for mechanical ventilation. The Company plans to offer hospitals receiving the INSPIRA™ ART100 an option with special terms for the integrated H ...

The event is an opportunity to present and demonstrate new products and technologies to potential customers and strategic partners RA'ANANA, Israel, June 5, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira Technologies"), a breakthrough medical technology company, is proud to announce plans to exhibit the INSPIRA™ ART100 System, recently cleared by the U.S. Food and Drug Administration ("FDA"), at the Extracorporeal Life Support Organizatio ...