Home Health News Dexcom over-the-counter Stelo Glucose Biosensor wins FDA clearance

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

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


An over-the-counter steady glucose monitoring (CGM) answer developed by Dexcom known as Stelo has obtained clearance from the Meals and Drug Administration (FDA).

Obtainable with out the necessity for a prescription, the wearable biosensor boasts a battery lifetime of as much as two weeks and adheres to the again of the higher arm. 

The patch aids within the detection of regular (euglycemic) in addition to low or excessive (dysglycemic) glucose ranges.

It offers round the clock glucose readings on to a smartphone and delivers customized insights into glucose well being, providing customers actionable info to make knowledgeable choices.

Tailor-made for people 18 and up who don’t require insulin, the goal group consists of these managing diabetes with oral medicines or people who want info on the impression of life-style elements like weight loss plan and train on blood sugar ranges.

The FDA clearance noted the system shouldn’t be indicated for people experiencing problematic hypoglycemia.

Stelo is slated to be accessible for buy on-line beginning in summer season 2024, and pricing shall be launched on the launch.


Approximately 38 million people in the U.S. are troubled with diabetes, with 90 to 95% of them having sort 2 diabetes. 

The mixing of CGM know-how has the potential to empower people managing diabetes by providing insights into the nuanced results of varied meals and bodily actions on their glucose ranges.

Glucose monitoring with smartphone connectivity eliminates the necessity for frequent finger sticks for therapy choices.

Dexcom additionally introduced a phased rollout of its “direct to Apple Watch” performance, beginning within the second quarter of this yr, which makes the CGM system able to connecting on to the Apple Watch with out requiring an iPhone. The characteristic shall be accessible to all G7 iOS customers.

DexCom is not the one participant in digital diabetes administration. Kakao Healthcare not too long ago launched its newest AI-driven mobile diabetes management app known as PASTA (Personalised, Accessible, Supportive, Tech-enabled, and Inexpensive).

The app hyperlinks to 2 CGM gadgets–the CareSens Air by producer i-SENS and Dexcom’s G7.

Valendo Health, a diabetes-focused endocrinology firm, provides telehealth and remote patient monitoring services staffed by diabetes care clinicians, an endocrinology-focused EMR, information analytics and help for value-based care contracting.



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