FDA Gives Go-ahead to Bayer’s CONTOUR

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The US Food and Drug Administration has okayed US sales of Bayer HealthCare’s CONTOUR® Next EZ blood glucose monitoring system. The new BGM, currently available in other countries as the CONTOUR XT, will be available in the US market this summer.

In a statement introducing the new BGM, Bayer says that it contains proprietary new blood glucose sensor technology whose accuracy “notably exceeds” the requirements of ISO 15197:2003. ISO 15197:2003, issued by the International Organization for Standardization, sets the requirements for accuracy in blood glucose monitoring systems used on a self-test basis to manage diabetes.

Bayer says the system’s proprietary electrochemical mediator and meter algorithm provide “a stable, high signal-to-noise ratio that facilitates accurate determination of blood glucose readings, even at low blood glucose levels.” The technology, according to Bayer, 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, such as acetaminophen or vitamin C.

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