HEMOLUNG COVID-19 Emergency Use Authorization
On April 22, 2020, ALung was issued Emergency Use Authorization (EUA) for the use of the HEMOLUNG to treat lung failure due to COVID-19.
- EUA FDA Letter of Authorization to ALung
- ALung Press Release announcing EUA
- FAQ’s – How to use HEMOLUNG for COVID-19 at your hospital
A public health emergency has been declared by the Secretary of Health and Human Services (HHS) on February 4, 2020. The FDA has issued an Emergency Use Authorization for the HEMOLUNG to treat lung failure caused by Coronavirus Disease 2019 (COVID-19).
Per the EUA, the FDA believes that the HEMOLUNG has the potential to treat lung failure as an adjunct to noninvasive or invasive mechanical ventilation, to reduce hypercapnia and hypercapnic acidosis due to COVID-19 and/or to maintain normalized levels of partial pressure of carbon dioxide (PCO2) and pH in patients suffering from acute, reversible respiratory failure due to COVID-19 for whom ventilation of CO2 cannot be adequately, safely, or tolerably achieved and, in turn, may provide clinical benefit.
For more information for the use of the HEMOLUNG at your site to treat COVID-19, please contact Hemolung_EUA@alung.com
- Hemolung EUA Fact Sheet for Providers
- Hemolung EUA Fact Sheet for Patients
- CR4 Hemolung Instructions For Use (for EUA use)
*This device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Hemolung under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.