December 21, 2007
Franklin Co. Secures European Approval For Med. Device
By Cory Hopkins
Franklin medical technology company PLC Systems Inc. has met all European safety requirements, and has received the CE Mark certificate for its RenalGuard System fluid replacement device.
The approval clears the way for the company to begin a limited launch of the product in the first quarter of 2008, beginning in Italy, the company said.
A distribution agreement with an Italian firm is close to finalization.
The launch in Italy will be supported by a previously announced clinical trial at the University of Milan that will use the RenalGuard technology in a study of contrast induced nephropathy, a condition that can lead to acute kidney failure in some high-risk patients.
The approval clears the way for the company to begin a limited launch of the product in the first quarter of 2008, beginning in Italy, the company said.
A distribution agreement with an Italian firm is close to finalization.
The launch in Italy will be supported by a previously announced clinical trial at the University of Milan that will use the RenalGuard technology in a study of contrast induced nephropathy, a condition that can lead to acute kidney failure in some high-risk patients.
WBJ Web Partners
Most Recent
Most Recent
0 Comments