Lung assist devices manufacturer ALung Technologies has obtained expedited access pathway (EAP) designation and priority processing status from the US Food and Drug Administration (FDA) for its Hemolung respiratory assist system (RAS).
The firm has developed Hemolung RAS to provide respiratory dialysis by removing carbon dioxide directly from the blood, helping in speedy recovery of patients with acute respiratory failure.
FDA has designed the new EAP program to facilitate rapid patient access to breakthrough technologies intended to treat or diagnose life-threatening or irreversibly debilitating diseases or conditions.
The device needs to meet one or more criteria, demonstrating that it addresses an unmet clinical need, to qualify for the program.
FDA admitted that the device may represent a breakthrough technology that provides a clinically meaningful advantage over existing legally marketed technology in its designation of EAP for the Hemolung RAS.
ALung Technologies chairman and CEO Peter DeComo said: "The EAP designation further validates that the current standard of care for COPD patients experiencing acute exacerbations can be improved," said Peter DeComo, Chairman and CEO of ALung.
"As one of the first companies selected for this program, we look forward to working with the FDA to make the Hemolung technology available in the United States as soon as possible."
Hemolung RAS obtained CE mark approval in 2013, and is also approved in 34 countries outside of the US, including Europe, Canada, and Australia.
In June this year, the firm received CE mark approval for its new Hemolung XG4 Cartridge and Catheter kits, which were designed for use under Hemolung RAS to provide respiratory dialysis.