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FDA Nod for DexCom's G4 PLATINUM System - Analyst Blog

San-Diego, CA-based DexCom, Inc. ( DXCM ) received U.S. Food and Drug Administration (FDA) approval for its DexCom G4 PLATINUM Professional Continuous Glucose Monitoring (CGM) System.

The Professional CGM System is a powerful, analytical tool that allows healthcare experts to treat patients who suffer from frequent hypoglycemia (low blood sugar), struggle to meet glycemic goals, or have wide fluctuations in glycemic variability.

Continuous glucose monitoring is extremely important for diabetes management. It helps regulate the glucose level by providing information on the direction and rate of glucose change and also alerts users in case of major fluctuations in the glucose level.

The PLATINUM Professional CGM System is the first and only real-time professional CGM which provides unblinded feedback, thus allowing patients to experience the benefits of real-time glucose monitoring.

Through real-time visibility of dynamic glucose changes, clinicians can coach their patients to better outcomes. The professional CGM System allows clinicians to retrospectively alter treatment after viewing the effects that specific foods, exercise, stress and medications have on their patients' glucose level.

How it Works?

The DexCom G4 PLATINUM Professional CGM consists of a medical practice-owned professional CGM system and sensors. Patients are placed on a professional CGM for a period of seven days - this involves minimal training and setup time.

During this period, dynamic and comprehensive data is collected that can be shared with the patients. Such information helps patients to understand the impact of their behavior on their glucose levels. It thus provides the doctor with an opportunity to review glucose data retrospectively with the patients to make therapeutic treatment recommendations.

By taking at least two calibrations from a blood glucose meter daily, the DexCom G4 PLATINUM Professional CGM provides continuous readings on the rate and direction of glucose change up to every five minutes.

The system can also be customized for personalized glucose targets and alerts and has an alarm feature to alert the user if glucose levels rise or fall to dangerous levels.

Going Forward

DexCom's mission is to provide doctors, patients and caregivers new medical technology to improve their understanding and management of diabetes.

The currently available professional CGM systems offer only retrospective, blinded information on the glucose level of patients. The novel DexCom G4 PLATINUM Professional CGM will enable clinicians to gain real-time insight into their patients' glycemic profiles leading to improved glucose control.

Over the long run, DexCom remains focused on replacing finger stick meters, the traditional standard-of-care for glucose monitoring, with CGM.

Zacks Rank

DexCom currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the medical instruments industry are Alphatec Holdings, Inc. ( ATEC ), RTI Surgical Inc. ( RTIX ) and Accuray Incorporated ( ARAY ). While Alphatec Holdings and RTI Surgical sport a Zacks Rank #1 (Strong Buy), Accuray carries a Zacks Rank #2 (Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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