FDA clears ACCU-CHEK Inform II
FDA clears ACCU-CHEK Inform II, Roche’s new hospital point-of-care system for blood glucose testing with improved accuracy and wireless data transfer Next-generation system also brings advances in patient care and durability
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.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com
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