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Dexcom Glucose Test System Approved For 2-Year-Olds

US FDA has heeded the advice of a July advisory committee that overwhelmingly supported expanding Dexcom's G5 Continuous Glucose Monitoring System for patients 2 and older. The company says the expanded indication will have a huge transformational effect on how patients with diabetes are treated and how such products are reimbursed.

Five months after an advisory panel overwhelmingly supported expanding Dexcom Inc.'s G5 Continuous Glucose Monitoring System for patients as young as 2 years old, US FDA has given the green light. The agency notes it is the first such test to be approved that does not also require traditional fingersticks to complement the product.

Alberto Guiterrez, director of the Office of In Vitro Diagnostics and Radiological Health at FDA’s device center, said in an agency press release that the approval could help reduce the...

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