Tag: Stelo
FDA gives greenlight to Dexcom OTC CGM
June 16, 2026HME News Staff
WASHINGTON – The U.S. Food and Drug Administration (FDA) has cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children: Dexcom’s Stelo Glucose Biosensor System, an integrated CGM (iCGM) indicated for people two years of age and older who do not use insulin. The FDA previously cleared the Stelo Glucose Biosensor System OTC for individuals 18 years and older in March 2024. “Children deserve access to the best tools available to manage their...
Edgepark targets broader customer, prescriber base
August 1, 2025Theresa Flaherty
TWINSBURG, Ohio – Innovations are expanding the number of people who can benefit from continuous glucose monitoring and a recent move by Edgepark to add the Dexcom Stelo and Eversense 365 to its portfolio allows the company to meet increased demand.
"To manage diabetes in the most optimal way is different for each individual, so we've really been focused on that as these innovations come to market,” said Kattrina Richardson, vice president of marketing, ADSG | Edgepark,...
Dexcom brings photo meal logging feature to Stelo
July 29, 2025HME News Staff
SAN DIEGO – Dexcom has released a new AI-powered photo meal logging feature to Stelo, the first over-the-counter glucose biosensor cleared by the Food and Drug Administration in the United States. The company previously released the feature for its Dexcom G7 earlier this year. “Diet plays a crucial role in managing glucose levels, and our new Smart Food Logging feature removes barriers to food tracking, making it easier to consistently log and understand the impact of meals,” said...
Dexcom to introduce OTC glucose sensor
March 6, 2024HME News Staff
SAN DIEGO – Dexcom has received clearance from the U.S. Food and Drug Administration for its Stelo by Dexcom, a continuous glucose monitor that will be available for people with Type 2 diabetes without a prescription. “Dexcom continues to lead innovation in the CGM market, with a long list of first-in-market advances,” said Jake Leach, executive vice president and COO. “Dexcom was the first to connect CGM to multiple insulin delivery devices, the first to connect CGM to a...