Inspira™ Announces 510(k) FDA Submission of INSPIRA™ ART100 Towards Commercialization

Inspira™ Technologies OXY BHN Ltd. 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.

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