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Inspira Technologies’ cardiopulmonary bypass system, Inspira ART100 gets US FDA 510(k) clearance

Inspira Technologies OXY B.H.N. Ltd., a pioneering company in medical technology, has announced that it has received 510(k) class II clearance from the US Food and Drug Administration (FDA) for its cardiopulmonary bypass system, the Inspira ART100.

This FDA clearance highlights the company's significant technological and innovative progress.

Inspira Technologies is a forward-thinking medical technology company specializing in life support systems. The Inspira ART (Gen 2), also referred to as the Inspira ART500, features the company's Adaptive Blood Oxygenation technology. This system is designed to continuously monitor a patient's blood parameters in real-time and deliver the required oxygen volume directly into the bloodstream.