June 1, 2007 DexCom has received U.S. Food and Drug Administration (FDA) approval for SEVEN, its 7-Day STS Continuous Glucose Monitoring System. SEVEN is DexCom’s second generation device designed to help people with diabetes better understand and manage their diabetes and control their glucose levels. At the same time, DexCom received FDA approval for its DM2 Data Manager software which allows continuous glucose data from the SEVEN receiver to be downloaded to a computer. The second generation software has new tools and analytical capabilities to provide further insight into an individual’s diabetes and facilitate more appropriate care. SEVEN and DM2 Data Manager will have a limited launch later this month.
Widely recognized as one of the leading causes of death and disability in the United States, diabetes is a chronic disease with no known cure that afflicts approximately 20 million people in the U.S. alone, according to the Center for Disease Control (CDC). In the U.S., diabetes is the leading cause of adult blindness, end stage kidney failure and lower limb amputations. People suffering from diabetes are also more significantly at risk for cardiovascular disease and stroke.