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Home » Diabetes: DexCom wins FDA nod for Smart remote glucose monitor

Diabetes: DexCom wins FDA nod for Smart remote glucose monitor

October 20, 2014 By Brad Perriello

Diabetes: DexCom wins FDA nod for Smart remote glucose monitor

Dexcom Inc. (NSDQ:DXCM) said it won pre-market approval from the FDA for a new device designed to connect up to 5 smartphones with its G4 Platinum continuous glucose monitor.

The DexCom Smart device uses a secure wireless connection to transmit a patient’s blood glucose data from the G4 Platinum to 5 designated recipients, according to a press release.

The recipients can remotely monitor blood glucose levels and receive alerts via the Smart system "from almost anywhere" using an Apple (NSDQ:AAPL) iPhone or iPod Touch, DexCom said.

"Dexcom Share represents a significant advance in diabetes care by allowing people with diabetes to share important glucose information with their loved ones from afar," CEO Terrance Gregg said in prepared remarks. "With Dexcom Share, users, parents and personal caregivers now have a new tool to dramatically improve how they communicate about their diabetes."

The Share device works via a dock that receives the G4 Platinum. The dock, which also recharges the CGM’s battery, sends glucose data to the Share app on the patient’s Apple device via Bluetooth. The dock also uploads the data to a secure server, from which the designated recipients can receive notifications and trends data, according to the release.

"Continuous glucose monitoring offers a unique opportunity for patients with diabetes to aim for glucose levels close to the reference range found in persons without diabetes," Dr. Lori Laffel of Boston’s Joslin Diabetes Center said in a statement. "The ability to share the continuous glucose data remotely, to almost any location, is a remarkable advance. This new device should help patients, families and care providers succeed with their overall efforts to improve diabetes control and prevent both short-term and long-term complications while preserving quality of life for patients with diabetes and their family members."

Filed Under: Diabetes, Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: Dexcom, Remote Patient Monitoring

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