Roche's hospital glucose monitor Accu-Chek Inform II garners FDA clearance
Top Story
By: Katie Bell
Ref: Roche, Chicago Tribune, 4-Traders
Published: 10/16/2012
Roche announced Tuesday FDA approval of its blood glucose monitor, the Accu-Chek Inform II system, for hospital point-of-care testing. Roland Diggelmann, chief operating officer at the company's diagnostics unit, noted that "this next-generation wireless system [offers] healthcare professionals new capabilities to help ensure the accuracy of test results, streamline data communications and provide optimal patient care."
Specifically, the device, which Roche indicated is expected to be available in the US this month, enables healthcare professionals to obtain test results in five seconds using a small 0.6 microlitre capillary blood sample, with no interference limitation from maltose, xylose or oxygen. An additional feature is the unique patient identifier to improve the accuracy of patient identification.
This is the third FDA approval for the Accu-Chek brand this year. In July, the regulator cleared Roche's Accu-Chek Combo system for insulin pump therapy and in the same month the company announced the availability of the previously approved Accu-Chek Nano SmartView system.
Separately, Roche announced Tuesday that third-quarter sales in its diagnostics unit reached 2.5 billion Swiss francs ($2.7 billion), up from 2.2 billion francs ($2.4 billion) in the year-ago period, with strong growth in its professional and tissue diagnostics units helping to offset a decline in its diabetes business, which suffered from ongoing price pressures and reimbursement cuts.
Specifically, the device, which Roche indicated is expected to be available in the US this month, enables healthcare professionals to obtain test results in five seconds using a small 0.6 microlitre capillary blood sample, with no interference limitation from maltose, xylose or oxygen. An additional feature is the unique patient identifier to improve the accuracy of patient identification.
This is the third FDA approval for the Accu-Chek brand this year. In July, the regulator cleared Roche's Accu-Chek Combo system for insulin pump therapy and in the same month the company announced the availability of the previously approved Accu-Chek Nano SmartView system.
Separately, Roche announced Tuesday that third-quarter sales in its diagnostics unit reached 2.5 billion Swiss francs ($2.7 billion), up from 2.2 billion francs ($2.4 billion) in the year-ago period, with strong growth in its professional and tissue diagnostics units helping to offset a decline in its diabetes business, which suffered from ongoing price pressures and reimbursement cuts.