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Xenios’s core products—including the Novalung system—are approved in major markets such as the US, Europe, and China for ECMO therapy. The company has received FDA clearance in the US for long-term ECMO use (>6 hours) and MDR approval in Europe for its latest generation device. Clinical results have established these systems as vital tools in intensive care medicine to improve survival rates among patients with severe cardiac or pulmonary failure.
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