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FDA Approval for DexCom's G4 PLATINUM
DexCom, Inc ( DXCM - Analyst Report) recently secured the U.S. Food and Drug Administration’s (FDA) approval for its continuous glucose monitoring (CGM) device - DexCom G4 PLATINUM (Pediatric). This CGM device is designed for use in children affected with diabetes aged between 2 and 17 years. The device had earlier been FDA approved for use among adults 18 years and older.
DexCom’s shares shot up as much as 8% in the trading session following the announcement. The stock has been up 2.6% since the news release.
Currently, the DexCom G4 PLATINUM (Pediatric) is the only available CGM system that has been approved for children as young as 2 years old.
The DexCom G4 PLATINUM can continuously track glucose levels for 7 consecutive days throughout the 24-hour period. This user-friendly wireless technology system facilitates viewing of the glucose levels as and when needed.
Unlike the conventional blood glucose meter, DexCom G4 PLATINUM CGM system displays the moving trends of the glucose levels, which in turn helps the user to undertake correct choices in proper diabetes management. Uncontrolled glucose levels pose potential health complications and can even lead to death. To battle this concern the CGM system is fitted with an in-built alarm that alerts when the glucose levels either rise or fall to dangerous levels.
DexCom has designed the product with a tiny sensor and wireless transmitter to make it easy for use in children. The DexCom G4 PLATINUM is also believed to be one of the smallest and lightest CGMs available in the market.
The FDA approval of the new DexCom G4 PLATINUM for use in children comes as a respite for parents who can easily monitor glucose levels on a regular basis without being bothered about the child being at home, or away at school, or even participating in sports activities.
Effective management of diabetes is essential as it is often associated to have long-term impacts on the health of people. It has been observed that ype 1 diabetes is more prevalent both in children as well as in young adults. With the availability of such a unique device, children are likely to better manage their diabetes going into adulthood. At the same, they will also be cautious about incorporating necessary lifestyle changes right from their early years.
The FDA approval for the DexCom G4 PLATINUM is a remarkable achievement in the field of diabetes management in the past 40 years, as diabetes is a grave health issue in the U.S as well as in other countries.
We believe that with the achievement of the FDA approval for this device, DexCom will gain access to a huge market, as various studies indicate that diabetes among children is alarmingly on the rise in the U.S.
Currently, DexCom carries a Zacks Rank #2 (Buy).
Investors interested in the medical instruments industry can also look at other well-placed stocks like Natus Medical Inc. ( BABY - Snapshot Report) , Echo Therapeutics, Inc. and Cyberonics Inc. . While Natus Medical carries a Zacks Rank #1 (Strong Buy) both Echo Therapeutics and Cyberonics carry a Zacks Rank #2 (Buy).