19 July 2012 | Regulatory | By BioSpectrum Bureau
Roche Accu-Chek Combo gets FDA approval
Singapore: Roche received clearance from the US FDA for its Accu-Chek Combo system for insulin pump therapy. The system seamlessly 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 but also allows for operating the insulin pump remotely. Furthermore, an easy-to-handle bolus advisor 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.
Mr Daniel O' Day, COO, Roche Diagnostics, said that, "We are very pleased to announce that our new insulin pump system will soon be available for people with diabetes in the US. With this clearance we are now looking forward to launch the second device in the US 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."
Mr Luc Vierstraete, head, Roche Diabetes Care, said, "The Accu-Chek Combo system clearly demonstrates Roche's dedication to integrated diabetes management solutions, combining the technical components for blood glucose monitoring, data management and insulin delivery. This new system is designed to support insulin pump patients in managing diabetes easily and discreetly in their everyday life."
The Accu-Chek Combo system has been launched successfully in several European and Asia-Pacific, including Australia. In addition to being discreet and easy-to-use, the Accu-Chek Combo system also features a full-color display that brings to life blood glucose data, insulin dose information and pump settings; flexibility to adjust the basal rate to as low as 0.05 units per hour in increments as precise as 0.01 units; and a large capacity insulin cartridge that holds up to 315 units of insulin.