ALung Technologies Gets FDA’s De Novo Clearance for Hemolung Respiratory System

ALung Technologies has received the FDA’s de novo clearance for its Hemolung respiratory assist system.

The Hemolung System is the first extracorporeal carbon dioxide removal device cleared by the FDA, according to Pittsburgh, Pa.-based ALung Technologies.

The Hemolung procedure takes up to five days in adults with acute, reversible respiratory failure for whom ventilation of carbon dioxide cannot be adequately or safely achieved using other available treatment options, the company said.