The Food and Drug Administration (FDA) has cleared diabetes-management firm DexCom’s (DXCM) new continuous glucose monitoring (CGM) system.
The San Diego, Calif.-based firm said its Dexcom G7 15 Day system had approved by the FDA to treat people 18 and older with diabetes. It is expected to launch in the U.S. in the second half of the year.
“By listening to the needs of our users, we’re proud to offer the longest lasting wearable and most accurate CGM, giving people the knowledge to better control their diabetes,” DexCom COO Jake Leach said.
Shares of DexCom rose nearly 10% Thursday morning to lead S&P 500 gainers on a day of broad market declines but pared advances and were little changed in recent trading. They have lost more than 50% of their value over the past year.
A month ago, the firm received a warning letter from the FDA over the condition of two of its manufacturing plants.
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