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Inspira Technologies Oxy BHN Ltd is a specialty medical device company focused on developing innovative respiratory support technology as an alternative to mechanical ventilation. By 2020, over 600,000 patients in the U.S. will need mechanical ventilation, with a significant portion requiring ICU admission, costing an estimated $64 billion annually. The company's OxyLink technology, an advanced nano vesicle device, introduces an intravascular oxygenation system to enhance blood oxygen levels and reduce carbon dioxide, enabling physicians to address primary ventilatory conditions effectively.
The company has recently received 510(k) class II clearance from the U.S. FDA for its INSPIRA ART100 Cardiopulmonary Bypass System. Inspira Technologies aims to revolutionize the respiratory care market with its innovative products, including the INSPIRA ART (Gen 2) system designed to elevate patient oxygen levels and potentially reduce the need for mechanical ventilation, providing new treatment alternatives and enhancing patient care.
Inspira Technologies OXY announced that its INSPIRA™ ART100 Cardiopulmonary Bypass System has received 510(k) class II clearance from the FDA.
The FDA clearance is a significant milestone for the company, suggesting technological and innovative advancements.
CEO Dagi Ben Noon and Chairman Professor Benad Goldwasser expressed their appreciation for investors and partners and highlighted the strategic importance of this clearance.
Inspira™ Technologies OXY B.H.N. (Nasdaq: IINN, IINNW) has announced the start of production of the INSPIRA ART100 medical device. The device is being contract manufactured by a leading technology company and the first batch will be used in initial sites pending FDA approval.
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