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Xvivo Perfusion: announces a timely FDA 510 (k) submission for kidney assist transport - Redeye

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.

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.
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