FDA clears ACCU-CHEK Inform II
Posted: 16 October 2012 | | No comments yet
Hospital point-of-care system for blood glucose testing with improved accuracy and wireless data transfer Next-generation system…
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for the ACCU-CHEK Inform II system, a next-generation blood glucose monitor for hospital point-of-care testing. The ACCU-CHEK Inform II system offers healthcare professionals the first truly wireless hospital blood glucose device. The system utilizes new patented technology to deliver improved accuracy and enables automatic real-time wireless transfer of patient data between hospital medical staff and the laboratory.
“Accuracy and patient safety are the foremost concerns for blood glucose testing in hospitals and other point-of-care settings,” said Roland Diggelmann, chief operating officer at Roche Diagnostics. “ACCU-CHEK systems have been proven in hospitals around the world and this next-generation wireless system sets a new standard by offering U.S. healthcare professionals new capabilities to help ensure the accuracy of test results, streamline data communications and provide optimal patient care.”
The US is the world’s key market in hospital blood glucose testing. In 2011 a total of 25.8 million adults and children in the U.S. suffered from diabetes. This is roughly a tenth of the U.S. population.
The system is expected to be available in the U.S. beginning in October 2012.
About the ACCU-CHEK Inform II system
With more than 2,750 hospital accounts and 117,000 ACCU-CHEK Inform systems in use in more than 48 countries, Roche leads in the world wide hospital blood glucose market. The next-generation technology in the ACCU-CHEK Inform II meter and test strip enables the healthcare professional to obtain test results in just five seconds using a small 0.6 microliter capillary blood sample. The system offers additional features for the hospital healthcare professional including unique patient identifiers to improve the accuracy of patient identification and a durable design to meet stringent new cleaning and disinfecting guidelines. In addition, new technology allows the meter and test strip to provide accurate test results with no interference limitation from maltose, xylose or oxygen. These results transfer quickly through the wireless network to give health care providers actionable information.
