Food and Drug Administration (FDA), United States, granted approval for the commercialization of Dexcom mobile medical app that would help in continuously monitoring glucose level in diabetic patients.
These are the first mobile medical apps, which would help patients dealing with diabetes to share their glucose level information with their doctors on real-time-basis and it also provides accuracy, security and remote access to the caregivers for the blood glucose level information. The patients can send the vital information automatically and very efficiently with the help of a continuous glucose monitor (CGM) and a portable mobile device.
CGM refers to a small device which is inserted under the skin and has small wire-like sensors. It enables the users to get a steadily streamlined data of the glucose levels in the blood. The Dexcom Share Direct Secondary Displays system offers data sharing between the patient and the caregiver that helps in better monitoring of the patients health.
Exempting devices from premarket review is part of the FDA's effort to ensure these products provide accurate and reliable results while still encouraging the development of devices that meet the needs of people living with diabetes and their caregivers, said Alberto Gutierrez, Director, In Vitro Diagnostics and Radiological Health department, FDA Center for Devices and Radiological Health.
With mobile apps and other portable devices making a market space for themselves in the diabetes industry, the market for glucose monitoring devices is set to witness a rapid growth in the demand, across the globe. There are various similar products available in the market for glucose monitoring, however, Dexcom Share is the first to be approved by the FDA.
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