Alung Technologies, a medical equipment manufacturing company in Pittsburg, has been granted De Novo clearance by the US Food and Drug Administration for its Hemolung Respiratory Assist System. Hemolung, which is based on the company’s extracorporeal carbon dioxide removal (ECCO2R) technology, is indicated for respiratory support that provides extracorporeal carbon dioxide (CO2) removal from the patient’s blood for up to 5 days in adults with acute, reversible respiratory failure for whom ventilation of CO2 cannot be adequately or safely achieved using other available treatment options. 

The FDA De Novo review process is designed to determine if the clinical benefits outweigh the clinical risks associated with a medical device when there is not a substantially equivalent predicate device. A company statement read that the device will provide extracorporeal carbon dioxide removal from the patient’s blood for upto 5 days in adults with respiratory failure. Medical experts have expressed hope at the new technology and how it would severely ill patients with severe respiratory diseases.