AngioDynamics (Albany, New York) said it has received clearance for its BioFlo Port with Endexo technology, a device designed to reduce the accumulation of cather-related thrombus on, and in, the port catheter. The company said the clearance of the BioFlo Port with Endexo technology marks the second U.S. clearance of a product line developed with BioFlo's technology.
The story of U.S.-based companies going overseas to develop and commercialize technology isn't an uncommon tale for the medical device industry. But what happens when firms based outside of the U.S. seek to gain FDA approval for an application and get a foothold in the states?