Dexcom wins FDA pediatric clearance for Stelo glucose sensor

DexCom, Inc. (NASDAQ: DXCM) announced that its Stelo Glucose Biosensor received FDA clearance earlier this month expanding its approved use to children ages 2 and older who are not using insulin, extending a previous indication limited to adults 18 and older.

The company made the announcement at the Aspen Ideas: Health conference, where it also outlined plans to launch a redesigned Stelo app in July for Apple iPhone and Android users in the United States. The updated app is intended to make glucose data more accessible to users tracking metabolic health.

According to the Centers for Disease Control and Prevention, the prevalence of Type 2 diabetes among children has risen significantly over the past 20 years, with projections suggesting cases could increase by 700%. A separate study cited by Dexcom found metabolic syndrome affects approximately 4.5% of youth under age 18 in the United States.

"Glucose matters for everyone and better understanding it can help prevent serious health complications," said Jake Leach, president and CEO of Dexcom. "That's why we're working to expand access to glucose biosensing to make preventive, personalized care a reality."

Dexcom also stated plans to expand Stelo availability internationally, with launches anticipated in the United Kingdom, Australia, New Zealand, and South Korea beginning later in 2026 and continuing into 2027.

Stelo is available without a prescription for individuals not using insulin.

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