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www.fdanews.com/articles/173903-fda-grants-eap-designation-to-alungs-hemolung-ras

FDA Grants EAP Designation to ALung’s Hemolung RAS

November 4, 2015

The FDA has granted an Expedited Access Pathway designation to ALung Technologies for its Hemolung Respiratory Assist System.

The device provides respiratory dialysis by removing carbon dioxide directly from the blood, facilitating lung rest, protection and recovery for patients suffering from acute respiratory failure.

The Hemolung technology also aims to avoid or reduce the need for intubation and ventilator support, as mechanical ventilation is associated with many harmful side effects. — Michael Cipriano