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Inspira™ Announces 510(k) FDA Submission of INSPIRA™ ART100 Towards Commercialization
September 13, 2023
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.
The Company’s vision is to transform external breathing assistance for over 20 million patients each year that require ventilation and oxygenation via external mechanical ventilation machinery. Legacy systems for breathing assistance are causing multiple complications leading to physical damage, infection and possible death. Inspira aims to revolutionize the medical ventilation and oxygenation market by delivering next-generation superior treatment, that will reduce the reliance on mechanical ventilation.
INSPIRA ART 100 was submitted today to the FDA post the completion of a comprehensive usability study in Boston, Massachusetts, with an expected approval timeline of approximately six months, which is targeted for the first half of 2024.
Dagi Ben-Noon, CEO of Inspira, stated that,
“We are preparing for global deployments of our INSPIRA ART100 systems once FDA clearance is achieved.
Our future systems can save millions of lives and change external respiratory aid for over 20 million people each year. We aim to be a part of this market over the next 5 years and are moving aggressively to achieve these goals.”
About Inspira Technologies OXY BHN Ltd.
Inspira Technologies maintains a steadfast mission to revolutionize acute respiratory care through innovation. The Company’s primary objective is the development of medical technologies and products aimed at preventing the necessity of mechanical ventilation. Its flagship product, the INSPIRA™ ART500, is intricately designed to rapidly elevate blood oxygen saturation levels, all while keeping patients conscious and alert. Moreover, the Company is dedicated to providing advanced blood circulation technology and integrating AI-driven monitoring and analytics. These elements combine to create patient-centric, data-driven solutions, ultimately enhancing patient outcomes and optimizing hospital efficiency.
See Full Press Release at the Source: Inspira™ Announces 510(k) FDA Submission of INSPIRA™ ART100 Towards Commercialization
Press Release by: Inspira Technologies
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