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

Sign up for free to continue

Already a member?

Sign in

Disclosures and disclaimers

Premium Plan required to unlock

Unlock companies to access

more high quality research.