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The Food and Drug Administration has given ARKRAY, Inc., a 510(k)* clearance to begin marketing its new GLUCOCARD® VitalTM blood glucose monitoring system in the United States.
ARKRAY, one of the world's largest manufacturers of diabetes self-monitoring systems, will begin distributing the meter and strip platform in early December. Channels will include the existing market for the GLUCOCARD line of products, as well as the mail order, managed care, home medical equipment, and durable medical equipment markets.
Features of the new BGM system include:
ARKRAY says that users of the new Vital system may participate in the company's YouChoose((TM)) wellness program, an education and support system that includes printed tools, videos, recipes, and a dedicated website designed to help patients manage their diabetes.
* 510(k) is the section of the Federal Food, Drug and Cosmetic Act from which the FDA derived its process for approving new medical devices. Gaining 510(k) approval means that the FDA has determined that a new device is "substantially equivalent" in safety and effectiveness to similar devices that are already on the market. The section does not require that such devices be made from the same materials as similar devices or based on the same technology-a fortunate bit of wiggle room that leaves the door open to innovation.
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3 comments - Nov 17, 2009
Diabetes Health is the essential resource for people living with diabetes- both newly diagnosed and experienced as well as the professionals who care for them. We provide balanced expert news and information on living healthfully with diabetes. Each issue includes cutting-edge editorial coverage of new products, research, treatment options, and meaningful lifestyle issues.