COVID-19: FDA Issues Emergency Use Authorization for Hemolung RAS
ALung is committed to the safety and support of health care professionals, patients, and employees in the treatment of COVID-19. The following represents ALung’s commitment to supporting FDA’s response to the COVID-19 pandemic in the United States.
FDA Issues Emergency Use Authorization for Hemolung RAS to treat COVID-19
On April 22, 2020, ALung was issued Emergency Use Authorization (EUA) for the use of the Hemolung Respiratory Assist System (RAS) to treat lung failure due to COVID-19.
- EUA FDA Letter of Authorizaton to ALung
- ALung Press Release announcing EUA
- FAQ’s – How to use Hemolung RAS 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 RAS to treat lung failure caused by Coronavirus Disease 2019 (COVID-19).
Per the EUA, the FDA believes that the Hemolung RAS 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 RAS and ECCO2R at your site to treat COVID-19, please contact Tracey Dill at Hemolung_EUA@alung.com.
- Review of ECCO2R in Acute Respiratory Failure
- Hemolung EUA Fact Sheet for Providers
- Hemolung EUA Fact Sheet for Patients
- Hemolung RAS Information
- Science of ECCO2R
- CR4 Hemolung RAS Instructions For Use
- CR3 Hemolung RAS Instructions For Use
- Summary of published COVID-19 literature
- Previous Hemolung RAS emergency/compassionate use in the United States
*The Hemolung RAS has not been FDA cleared or approved;
*The Hemolung RAS has been authorized for the above emergency use by FDA under an EUA;
*This device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Hemolung RAS under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.