Bridge to Life has received FDA De Novo clearance for its VitaSmart hypothermic oxygenated perfusion (HOPE) system for liver ...

Bridge to Life™ Ltd., a global innovator in organ preservation and perfusion technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo clearance for the ...

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-in-human cases ...

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 ...

Paris-based medical device startup Tulyp Medical has emerged from stealth and submitted a 510(k) application to FDA for its intelligent pressure-driven perfusion device. The company has seen positive ...

Bridge to Life gets US FDA De Novo clearance for VitaSmart HOPE System, the first device cleared in the US for hypothermic oxygenated perfusion of donor livers: Duluth, Georgia We ...

The FDA clearance enables the commercial use of VitaSmart (TM) for hypothermic oxygenated perfusion of donor livers following static cold storage and prior to transplantation, providing a clear, ...