XVIVIO announces a timely FDA 510 (k) submission for Kidney Assist Transport
Research Note
2021-05-04
09:44
Redeye's take is that a typical 510 (k) submission is followed by a 90-120 review time, and this opens up for a launch in late 2021. The main point is that a launch allows XVIVO to start exploring the late 2020 Organ Assist acquisition and the future benefits of hypothermic oxygenated perfusion of the donor's kidney.
JU
Johan Unnerus
Disclosures and disclaimers