FDA Grants De Novo Designation to ALung Technologies’ Respiratory Assistance System

The FDA has granted De Novo authorization to ALung Technologies’ Hemolung respiratory assist system (RAS).

The agency defines the new generic type of device as an extracorporeal system for carbon dioxide removal from the blood of patients with acute respiratory failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

The Hemolung RAS provides low blood flow carbon dioxide removal using a single, 15.5 French dual lumen catheter inserted percutaneously in the femoral or jugular vein. It is not intended to provide therapeutic levels of oxygenation.