Replies to post #8560 on CytoSorbents Corporation (CTSO)

[orangecat]

From the article "A large-scale U.S. randomized, controlled trial called REFRESH (REduction in FREe Hemoglobin) II, intended to support FDA approval of CytoSorb, will start later this year."

I think "Large-scale" is further confirmation of the PMA route rather than 510K.