The U.S. Food and Drug Administration (FDA) has cleared the use of Dexcom’s (DXCM.O), opens new tab device, making it the first continuous glucose monitor to be available over the counter, the health regulator said on Tuesday.
Dexcom’s shares experienced a surge of 2.2% in extended trading.
The device- Stelo is intended for use in patients who are of 18 years age and older who do not use insulin, such as those with diabetes managing their condition with oral medications or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels.Dexcom’s Stelo is not for individuals with problematic hypoglycemia or low blood sugar as it is not designed to aware the user about this potentially dangerous condition, the FDA said.
The device uses a wearable sensor, paired with an application on the user’s smartphone or other smart device to continuously measure blood glucose levels for a better understanding and knowing their parameters timely.
Stelo will be available for purchase online without a prescription at a competitive price starting in summer 2024, the company said, adding that it plans to share additional pricing details then.