DXCM · 10-Q · 2026Q3 · Full report
Regulatory Approval Milestones
DEXCOM INC · 2026-10-29 · Importance 29 · Surprise 42 · In source text
In June 2026, the FDA cleared Stelo for use by children ages 2 years and older who do not use insulin. Stelo was launched in the United States in August 2024 as the first over-the-counter glucose biosensor for adults with prediabetes and Type 2 diabetes who do not use insulin. The filing does not quantify the financial impact of the expanded indication.
Key facts
- In June 2026, Stelo received FDA clearance to expand its indication to children ages 2 years and older who do not use insulin. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | contingent | — | In June 2026, Stelo received FDA clearance to expand its indication to children ages 2 years and older who do not use insulin. |