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First medical app system to monitor glucose cleared in U.S.

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(Bloomberg) — DexCom Inc. won U.S. clearance for the first system of glucose-monitoring apps that can be used with mobile devices such as the iPhone to remotely track the health of a diabetic.

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The Food and Drug Administration (FDA) gave the green light to the Dexcom Share system, which transmits data from a small, wire-like sensor inserted just under the skin, according to a statement Friday from the agency. Photos show users taping the sensors to their stomachs. Other similar systems exist, but none has been cleared for sale by the agency since the FDA began regulating mobile medical applications as devices in 2013.

The subcutaneous sensor sends glucose levels continuously to a monitor that is worn externally, and the Dexcom Share system allows the information to be shared by the user. The app downloads the data for followers from a Web-based storage location, the FDA said.

“This innovative technology has been eagerly awaited by the diabetes community, especially caregivers of children with diabetes who want to monitor their glucose levels remotely,” Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the statement.

An estimated 25.8 million people in the U.S. have diabetes and about 215,000 of them are younger than 20, according to the FDA. People with the disease can’t make or properly use insulin produced by the body to convert glucose in the blood into energy. Diabetics have a greater risk of heart disease and serious damage to their eyes, nerves and kidneys.

The marketing approval of San Diego-based DexCom’s system should pave the way for similar technologies to be sold in the U.S., Gutierrez said.

The agency cleared the app system through its de novo process, which is a regulatory pathway for low-to moderate-risk devices that doesn’t require the same rigorous review as more complicated products.

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