Pedra Technology announced the FDA granted breakthrough device designation for periprocedural use of its perfusion system for the treatment of critical limb ischemia. “With the Xauron device, ...
Paragonix Technologies Receives FDA 510(k) Clearance for KidneyVault Portable Renal Perfusion System
WALTHAM, Mass.--(BUSINESS WIRE)--Paragonix Technologies, a pioneer in organ transplant technologies and organ procurement services, received U.S. Food and Drug Administration (FDA) 510(k) clearance ...
WALTHAM, Mass.--(BUSINESS WIRE)--Paragonix Technologies, a pioneer in organ transplant technologies and organ procurement services, announced today the completion of the world’s first donor kidney ...
Share on Facebook. Opens in a new tab or window Share on Bluesky. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window Patients who ...
Organox Ltd.’s normothermic machine perfusion device, Metra, has been cleared by the U.S. FDA for use during air transport. The greenlight from the regulatory body paves the way for the broader use of ...
Donor lungs are usually flushed and preserved at cold temperatures before transplantation. The cold temperature reduces tissue decomposition, but can also result in degradation of the organ and a ...
New Modes Are Beginning to Gain Ground on Fed-batch Strategy The therapeutic success of highly efficacious complex biologicals that are almost exclusively produced in cell culture such as antibodies ...
TransMedics' Organ Care System liver perfusion device got near unanimous support for an indication in liver transplantation by an FDA advisory committee. The agency's Gastroenterology and Urology ...
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