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BioWorld - Saturday, March 14, 2026
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Home » Hemolung respiratory assist system gets de novo nod
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Hemolung respiratory assist system gets de novo nod

Nov. 15, 2021
By Annette Boyle
Patients and investors in Alung Technologies Inc. can breathe a little easier now that the company’s Hemolung respiratory assist system has won a de novo approval from the FDA. The FDA approval comes more than eight years after Hemolung received CE mark and Health Canada approval. Hemolung gained FDA emergency use authorization for patients with COVID-19 in April 2020.
Medical technology Respiratory Coronavirus U.S. De novo FDA

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