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Home » Dexcom submits new glucose sensor to FDA, expects launch this summer

Dexcom submits new glucose sensor to FDA, expects launch this summer

January 9, 2024 By Sean Whooley

Dexcom Stelo glucose monitor
The Stelo glucose monitor. [Image courtesy of Dexcom]
Dexcom (Nasdaq: DXCM) announced that it submitted its new Stelo glucose sensor to the FDA for review at the end of last year.

The continuous glucose monitor (CGM) maker designed Stelo specifically for people with type 2 diabetes who do not use insulin. San Diego-based Dexcom designed Stelo for a 15-day wear with a cash-pay option. It features a software experience tailored specifically for non-insulin users.

In early 2023, Dexcom Chair, President and CEO, Kevin Sayer hinted at potential new avenues when speaking to Drug Delivery Business News. He explained that the company wanted to broaden its focus, even revising its mission statement.

At the company’s June Investor Day event, it revealed its plans to bring the new product to market in the U.S. in 2024. According to Dexcom, the target population includes approximately 70% of Americans with diabetes.

Dexcom expects to launch Stelo in the U.S. in the summer of 2024.

“Understanding glucose levels is key to unlocking our metabolic health, and Stelo will help users see first-hand how their health is affected by factors such as diet, exercise, sleep and stress,” said Jake Leach, Dexcom EVP and COO, during the company’s preliminary earnings announcement yesterday.

Get the full story at our sister site, Drug Delivery Business News.

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Health Technology, News Well, Patient Monitoring, Regulatory/Compliance Tagged With: Dexcom, FDA

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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