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FDA Approves DexCom Share Update, Downclassifies CGM Accessory

The agency approved DexCom’s new Share CGM receiver that works without a cradle and allows diabetes patients to share their medical data from anywhere. It also reclassified such devices to no longer require a premarket submission.

FDA approved DexCom Inc.’s updated G4 Platinum Continuous Glucose Monitoring System with Share on Jan. 23 and announced it has downclassified the accessory receiver that comes with the system and other such devices to not require a premarket submission. The agency already approved the system back in October but the new receiver does not need to be connected to a cradle, making it more mobile. (See [A#01141027004].)

The company filed the continuous blood glucose monitoring system under FDA’s de novo classification process and says it “could not be more pleased”

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