FDA Clears Accu-Chek Combo System
Roche announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for the Accu-Chek Combo system for insulin pump therapy. The Accu-Chek Combo system combines a blood glucose meter with an insulin pump, which are able to exchange data in both directions via Bluetooth wireless technology. The meter not only enables the user to quickly test blood glucose levels: It allows for operating the insulin pump remotely and by means of an easy-to-handle bolus advisor it provides support in defining the right amount of insulin. With this the Accu- Chek Combo system not only supports a more targeted therapy management, but it also allows for a discreet insulin administration without the need to touch the pump.
"We are very pleased to announce that our new insulin pump system will soon be available for people with diabetes in the U.S.," said Daniel O' Day, COO Roche Diagnostics. "With this clearance we are now looking forward to launch the second device in the U.S. this year, after the successful clearance of the Accu-Chek Nano SmartView system in the first quarter. Both launches represent a significant milestone for our Diabetes Care business."
According to the 2011 National Diabetes Fact Sheet published by the Centers for Disease Control and Prevention, more than 25 million people in the U.S. live with diabetes. It is also estimated that 79 million people live with pre-diabetes in the U.S.