This section highlights FDA-related milestones and regulatory updates for drugs developed by DexCom (DXCM).
Over the past two years, DexCom has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Dexcom and G7. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Dexcom G7 FDA Regulatory Events
Dexcom G7 is a drug developed by DexCom for the following indication: Next-Generation Continuous Glucose Monitoring System (CGM).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Dexcom G7
- Announced Date:
- November 19, 2025
- Indication:
- Next-Generation Continuous Glucose Monitoring System (CGM)
Announcement
DexCom, Inc the FDA has cleared Dexcom Smart Basal, the first and only CGM-integrated basal insulin dosing optimizer designed for adults with Type 2 diabetes on glargine U-100 long-acting insulin therapy.1 Dexcom Smart Basal will use Dexcom G7 15 Day sensor data and logged doses to calculate personalized daily recommendations to guide users towards a more effective long-acting insulin dose, as directed by their healthcare provider.
AI Summary
Dexcom announced FDA clearance of Dexcom Smart Basal, the first and only CGM‑integrated basal insulin dosing optimizer for adults (18+) with Type 2 diabetes using glargine U‑100 long‑acting insulin. The feature uses data from the Dexcom G7 15 Day sensor plus logged insulin doses to calculate personalized daily recommendations, aiming to guide users toward a more effective long‑acting insulin dose as directed by their healthcare provider.
Smart Basal starts with an initial dose set by a clinician, then delivers daily dose suggestions and reminders in the G7 15 Day app. Unlike single fasting glucose checks, it analyzes all CGM readings to adjust recommendations and will reduce suggested doses if low glucose events occur based on provider settings. When glucose stays consistently in the target range, Smart Basal completes. The tool can be prescribed and configured via Dexcom Clarity and will be added to the G7 15 Day experience in the U.S., with efforts underway for international availability.
Read Announcement- Drug:
- Dexcom G7
- Announced Date:
- June 20, 2024
- Indication:
- Next-Generation Continuous Glucose Monitoring System (CGM)
Announcement
DexCom, Inc. the global leader in real-time continuous glucose monitoring (CGM) for people with diabetes, will showcase its expanding focus on Dexcom CGM use among people with Type 2 diabetes, the launch of the Omnipod 5 Automated Insulin Delivery System with Dexcom G7 and its relentless commitment to innovation at the 84th Scientific Sessions of the American Diabetes Association conference held June 21–24, 2024, in Orlando.
AI Summary
Dexcom, Inc.—the global leader in real-time continuous glucose monitoring—will highlight major innovations at the 84th Scientific Sessions of the American Diabetes Association in Orlando, Florida, from June 21–24, 2024. At the event, Dexcom will showcase its expanding focus on CGM use among people with Type 2 diabetes, presenting new clinical data that demonstrates significant improvements in A1C levels and increased time in range. The company is also launching the Omnipod 5 Automated Insulin Delivery System powered by its latest Dexcom G7 sensor, reinforcing its leading position in connected diabetes care.
In addition to these advancements, Dexcom emphasizes its relentless commitment to innovation with new app updates—including Direct to Apple Watch connectivity—to enhance user experience. These developments underline Dexcom’s mission to simplify diabetes management and improve outcomes for a wide range of users.
Read Announcement
G7 15 FDA Regulatory Events
G7 15 is a drug developed by DexCom for the following indication: Continuous Glucose Monitoring System.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- G7 15
- Announced Date:
- April 10, 2025
- Indication:
- Continuous Glucose Monitoring System
Announcement
DexCom, Inc announced today the FDA has cleared the Dexcom G7 15 Day Continuous Glucose Monitoring System for people over the age of 18 with diabetes in the United States.
AI Summary
Dexcom, Inc. announced that the FDA has cleared its Dexcom G7 15 Day Continuous Glucose Monitoring System for use by people aged 18 and older with diabetes in the United States. This clearance marks a significant advancement in continuous glucose monitoring, as the G7 15 Day is recognized as the longest lasting CGM system available, with sensors designed for up to 15.5 days of wear. The sensor offers best-in-class accuracy with an overall Mean Absolute Relative Difference (MARD) of 8.0%, giving users reliable readings to better manage their diabetes. With this innovative technology, adults with diabetes can benefit from improved tracking of their glucose levels, potentially leading to better glycemic control and increased time in range. Dexcom plans to launch the new device in the U.S. later this year, solidifying its leadership in diabetes care technology.
Read Announcement
