These guys got EUA based solely on potential....
Post# of 148175
FDA Grants ALung Emergency Use Authorization (EUA) to the Hemolung® Respiratory Assist System (RAS) for the Treatment of COVID-19
April 24, 2020
Media Coverage, Press Release, Recent News
PITTSBURGH – April 24, 2020 –
ALung submitted and the FDA reviewed in vitro and in vivo information in support of ALung’s ongoing U.S. VENT-AVOID clinical trial ....
Based on the information submitted, the FDA stated that it believes the Hemolung RAS has the potential to treat lung failure as an adjunct to noninvasive or invasive mechanical ventilation