Dexcom over-the-counter Stelo Glucose Biosensor wins FDA clearance

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Over-the-counter continuous glucose monitoring (CGM) solution developed by Dexcom, called Stelo, has been cleared by the Food and Drug Administration (FDA).

Available without a prescription, this wearable biosensor has a battery life of up to two weeks and is attached to the back of the upper arm.

This patch helps detect normal (euglycemic) and hypoglycemic or hyperglycemic (dysglycemic) glucose levels.

It provides 24-hour blood sugar readings directly to your smartphone, provides personalized insights into your blood sugar health, and provides users with actionable information to make informed decisions.

Tailored for individuals over the age of 18 who do not require insulin, target groups include those who manage their diabetes with oral medications and those who are aware of the effects of lifestyle factors such as diet and exercise on blood sugar levels. This includes people who need information.

FDA approval I got it. This system is not indicated for people with problematic hypoglycemia.

Stelo will be available for purchase online starting summer 2024, with pricing to be announced at launch.

bigger trends

Approximately 38 million people in the United States People suffer from diabetes, and 90-95% of them have type 2 diabetes.

The integration of CGM technology has the potential to empower individuals in managing diabetes by providing insight into the subtle effects that different foods and physical activity have on blood sugar levels.

Smartphone-connected blood sugar monitoring eliminates the need for frequent finger pricks to make treatment decisions.

Dexcom also announced that starting in the second quarter of this year, it will gradually roll out its “Direct to Apple Watch” feature, which allows CGM systems to connect directly to the Apple Watch without the need for an iPhone. This feature will be available to all his G7 iOS users.

DexCom is not the only player in digital diabetes management.Kakao Healthcare recently launched its latest product PASTA (Personalized, Accessible, Supportive, Tech-enabled, Affordable), an AI-powered mobile diabetes management app.

This app links CareSens Air and two CGM devices from the manufacturer i-SENS. Dexcom G7.

Valend healthis a diabetes-focused endocrinology company offering diabetes care clinician-staffed telemedicine and remote patient monitoring services, endocrinology-focused EMR, data analytics, and value-based care contract support. It offers.

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