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DXCM Receives FDA Clearance for Stelo OTC CGM System for Children
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Key Takeaways
DexCom received FDA clearance for Stelo use in children above 2 years of age who do not use insulin.
Stelo delivers glucose readings and trends every 15 minutes through a compatible smartphone.
Built on DexCom's G7 platform, Stelo offers up to 15 days of sensor wear and app insights.
DexCom (DXCM - Free Report) received FDA clearance for its Stelo Glucose Biosensor System for use in children aged two years and older who do not use insulin. The clearance expands access to the company’s over-the-counter (OTC) continuous glucose monitoring (CGM) system, which was previously approved for adults aged 18 years and older in March 2024.
Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, stated that children should have access to the best tools available to manage their health. The clearance underscores the agency’s commitment to encouraging innovation in medical devices designed for pediatric patients.
Likely Trend of DXCM Stock Following the News
Shares of DexCom have lost 1.5% since the announcement on Friday. Year to date, the stock has gained 11.8%, outperforming the industry’s 17% decline and the S&P 500’s 10.4% rise.
The FDA clearance of Stelo for pediatric use may strengthen DexCom’s position in the growing diabetes technology market. By expanding the addressable market beyond adults, the company can reach a larger population of children with diabetes, prediabetes and other individuals seeking greater awareness of glucose levels. The development is expected to support long-term growth opportunities while reinforcing DexCom’s leadership in continuous glucose monitoring solutions.
DXCM currently has a market capitalization of $29.08 billion.
Image Source: Zacks Investment Research
More on the News
Stelo is the first FDA-cleared OTC CGM system available for children who do not use insulin. The wearable sensor is designed to continuously measure glucose levels and deliver insights directly to a compatible smartphone through the Stelo app. The device provides glucose readings and trend information every 15 minutes and can be connected to a caregiver’s smartphone for monitoring support.
Built on DexCom’s G7 platform, Stelo offers up to 15 days of sensor wear and is intended for children with diabetes who manage their condition using oral medications, as well as individuals seeking to understand how diet, exercise and lifestyle choices affect glucose levels. The system is designed to provide greater glycemic awareness and help users identify patterns that can support healthier long-term outcomes.
The pediatric clearance follows recent enhancements to the Stelo app platform, including AI-powered features such as pattern recognition, personalized summaries and proactive coaching. These tools are intended to provide a more intuitive experience for users seeking deeper insights into their metabolic health and glucose trends.
Industry Prospects Favoring the Market
Going by the data provided by Grandview Research, the continuous glucose monitoring (CGM) devices market was valued at $15.47 billion in 2026 and is expected to witness a CAGR of 15.1% through 2033.
Factors like the growing cases of diabetes, the increasing adoption of CGM devices, growing clinical needs, technological innovation and shifting care models are boosting the market’s growth.
Other News
At the recent Investor Day event, DexCom unveiled its next-generation CGM, the Dexcom G8 system, which is expected to be launched in late 2027 or early 2028. Features include step change improvement in glucose performance, a 50% smaller form factor than Dexcom G7 and advanced sensing capabilities.
West Pharmaceutical, sporting a Zacks Rank #1 (Strong Buy) at present, reported first-quarter 2026 earnings per share (EPS) of $2.13, which beat the Zacks Consensus Estimate by 26.8%. Revenues of $844.9 million surpassed the Zacks Consensus Estimate by 8.5%. You can see the complete list of today’s Zacks #1 Rankstocks here.
West Pharmaceutical has an estimated long-term earnings growth rate of 13.9%. WST’s earnings surpassed estimates in the trailing four quarters, the average surprise being 19.4%.
Globus Medical, currently carrying a Zacks Rank #2 (Buy), reported first-quarter 2026 adjusted EPS of $1.12, which surpassed the Zacks Consensus Estimate by 22.1%. Revenues of $759.9 million beat the Zacks Consensus Estimate by 4.0%.
Globus Medical has an estimated long-term earnings growth rate of 10.2%. GMED’s earnings beat estimates in the trailing four quarters, the average surprise being 26.3%.
Biodesix, currently carrying a Zacks Rank of 2, reported a first-quarter 2026 adjusted loss per share of 81 cents, which was 35.71% narrower than the Zacks Consensus Estimate. Revenues of $26 million beat the Zacks Consensus Estimate by 12.3%.
BDSX has an estimated earnings growth rate of 36% for 2026. The company beat earnings estimates in three of the trailing four quarters and missed once, the average surprise being 25.6%.
View the Zacks #1 Rank List
Image: Bigstock
DXCM Receives FDA Clearance for Stelo OTC CGM System for Children
Key Takeaways
DexCom (DXCM - Free Report) received FDA clearance for its Stelo Glucose Biosensor System for use in children aged two years and older who do not use insulin. The clearance expands access to the company’s over-the-counter (OTC) continuous glucose monitoring (CGM) system, which was previously approved for adults aged 18 years and older in March 2024.
Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, stated that children should have access to the best tools available to manage their health. The clearance underscores the agency’s commitment to encouraging innovation in medical devices designed for pediatric patients.
Likely Trend of DXCM Stock Following the News
Shares of DexCom have lost 1.5% since the announcement on Friday. Year to date, the stock has gained 11.8%, outperforming the industry’s 17% decline and the S&P 500’s 10.4% rise.
The FDA clearance of Stelo for pediatric use may strengthen DexCom’s position in the growing diabetes technology market. By expanding the addressable market beyond adults, the company can reach a larger population of children with diabetes, prediabetes and other individuals seeking greater awareness of glucose levels. The development is expected to support long-term growth opportunities while reinforcing DexCom’s leadership in continuous glucose monitoring solutions.
DXCM currently has a market capitalization of $29.08 billion.
Image Source: Zacks Investment Research
More on the News
Stelo is the first FDA-cleared OTC CGM system available for children who do not use insulin. The wearable sensor is designed to continuously measure glucose levels and deliver insights directly to a compatible smartphone through the Stelo app. The device provides glucose readings and trend information every 15 minutes and can be connected to a caregiver’s smartphone for monitoring support.
Built on DexCom’s G7 platform, Stelo offers up to 15 days of sensor wear and is intended for children with diabetes who manage their condition using oral medications, as well as individuals seeking to understand how diet, exercise and lifestyle choices affect glucose levels. The system is designed to provide greater glycemic awareness and help users identify patterns that can support healthier long-term outcomes.
The pediatric clearance follows recent enhancements to the Stelo app platform, including AI-powered features such as pattern recognition, personalized summaries and proactive coaching. These tools are intended to provide a more intuitive experience for users seeking deeper insights into their metabolic health and glucose trends.
Industry Prospects Favoring the Market
Going by the data provided by Grandview Research, the continuous glucose monitoring (CGM) devices market was valued at $15.47 billion in 2026 and is expected to witness a CAGR of 15.1% through 2033.
Factors like the growing cases of diabetes, the increasing adoption of CGM devices, growing clinical needs, technological innovation and shifting care models are boosting the market’s growth.
Other News
At the recent Investor Day event, DexCom unveiled its next-generation CGM, the Dexcom G8 system, which is expected to be launched in late 2027 or early 2028. Features include step change improvement in glucose performance, a 50% smaller form factor than Dexcom G7 and advanced sensing capabilities.
DexCom, Inc. Price
DexCom, Inc. price | DexCom, Inc. Quote
DXCM’s Zacks Rank & Key Picks
DexCom currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are West Pharmaceutical (WST - Free Report) , Globus Medical (GMED - Free Report) and Biodesix (BDSX - Free Report) .
West Pharmaceutical, sporting a Zacks Rank #1 (Strong Buy) at present, reported first-quarter 2026 earnings per share (EPS) of $2.13, which beat the Zacks Consensus Estimate by 26.8%. Revenues of $844.9 million surpassed the Zacks Consensus Estimate by 8.5%. You can see the complete list of today’s Zacks #1 Rankstocks here.
West Pharmaceutical has an estimated long-term earnings growth rate of 13.9%. WST’s earnings surpassed estimates in the trailing four quarters, the average surprise being 19.4%.
Globus Medical, currently carrying a Zacks Rank #2 (Buy), reported first-quarter 2026 adjusted EPS of $1.12, which surpassed the Zacks Consensus Estimate by 22.1%. Revenues of $759.9 million beat the Zacks Consensus Estimate by 4.0%.
Globus Medical has an estimated long-term earnings growth rate of 10.2%. GMED’s earnings beat estimates in the trailing four quarters, the average surprise being 26.3%.
Biodesix, currently carrying a Zacks Rank of 2, reported a first-quarter 2026 adjusted loss per share of 81 cents, which was 35.71% narrower than the Zacks Consensus Estimate. Revenues of $26 million beat the Zacks Consensus Estimate by 12.3%.
BDSX has an estimated earnings growth rate of 36% for 2026. The company beat earnings estimates in three of the trailing four quarters and missed once, the average surprise being 25.6%.