U.S. FDA Clears Bayer HealthCare’s CONTOUR® Next EZ Blood Glucose Monitoring System
TARRYTOWN, N.Y., April 18, 2012 /PRNewswire/ — Bayer HealthCare today announced that the U.S. Food and Drug Administration (FDA) has cleared its CONTOUR® Next EZ, a new blood glucose monitoring (BGM) system for use in the United States. CONTOUR Next EZ includes an easy-to-use meter and test strip sensors with innovative technology for advanced accuracy. Bayer’s new BGM system is being introduced on a market-by-market basis and is currently available in other countries as CONTOUR XT. In the U.S., CONTOUR Next EZ will be available this summer.
With Bayer’s proprietary new blood glucose sensor technology, the CONTOUR Next EZ system delivers advanced accuracy that notably exceeds the requirements of ISO 15197:2003. The proprietary electrochemical mediator and meter algorithm utilized in the CONTOUR Next EZ blood glucose monitoring system provides a stable, high signal-to-noise ratio that facilitates accurate determination of blood glucose readings, even at low blood glucose levels. The new technology also ensures that the system remains accurate under a wide range of storage conditions, corrects for common errors and is not affected by hematocrit or many common interfering substances in the blood (e.g. acetaminophen, vitamin C).
The new CONTOUR Next EZ system was tested in a number of studies,,,, around the globe in which it consistently showed excellent performance in the hands of healthcare providers as well as patients.
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 16.913 billion (2010), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2010) and is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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SOURCE Bayer HealthCare