FDA gives thumbs up to new glucose monitoring device


The FDA approves Dexcom's (DXCM -2%) G4 Platinum Professional CGM (continuous glucose monitoring) device that monitors glucose levels in real time.

The product consists of a medical clinic-owned CGM system and sensors. Patients are set up for a period of seven days during which real time data are collected and can be shared with the patient. On the basis of two calibrations from a blood glucose meter daily, the G4 provides continuous readings on the rate and direction of glucose change as frequently as every five minutes. Physicians can then adjust therapy more rapidly. The G4 can be customized for personal glucose targets/alerts and has an alarm feature to alert the patient if glucose levels drift out of range.

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