www.fdanews.com/articles/207158-xvivo-awarded-eu-medical-device-regulation-certificate-for-kidney-assist-transport
Xvivo Awarded EU Medical Device Regulation Certificate for Kidney Assist Transport
March 29, 2022
Xvivo Perfusion has received the EU’s Medical Device Regulation (MDR) certification for its Kidney Assist Transport device.
The device is a transportable organ perfusion system that allows for continuous oxygenation of kidneys for up to 24 hours.
The device features adjustable perfusion pressure and flow settings, back-up cold storage, and a bag for protection of the graft and the machine.
The transport device has been shown to improve preservation compared to cold storage, the Gothenburg, Sweden-based company said.