Upcoming Dexcom G7 continuous glucose monitor secures European CE Mark with FDA clearance and Apple Watch compatibility also on the cards
A few days ago, we reported about how the Dexcom G7 seemed to be nearing its European launch thanks to the discovery of cached pages signposting this development. Dexcom has now issued a press release to confirm that the Dexcom G7 has received its European CE Mark, bringing it one important step closer to release. The company actually mentions upcoming availability projections for the latest iteration of its popular CGM device, stating “Dexcom expects to initiate a launch of Dexcom G7 in Europe in the next several weeks”.
For those wondering about a potential US release for the Dexcom G7, there is a small update that indicates there is still some considerable waiting time ahead. The press release reveals that the CGM is “pending 510(k) clearance” with the FDA and that a submission was made in Q4 2021. The FDA points out that this notification should be made “at least 90 days in advance” of intended marketing. For comparison, the Dexcom G6 Pro CGM was cleared by the FDA in October 2019 but shipping of the device to healthcare providers started in July 2020.
The Dexcom G7 promises to bring plenty of improvements with it compared to the predecessor G6 CGM, including being 60% smaller, only taking 30 minutes for sensor warmup, and offering a 12-hour grace period for sensor changing. Excitingly, there are also plans to create software that will allow the Dexcom G7 CGM to have direct communication with the Apple Watch, making it easier for those with diabetes to keep a close eye on their glycemic state.
Fingersticks won't be required for general usage, although should still be at hand if the CGM offers unexpected readings and further checking is needed. The small CGM device can be worn on the upper arm or abdomen, while younger users with diabetes can also have the Dexcom G7 applied to the upper buttock area (press release states ages 2-17 in line with the G6, product page says ages 2-6 in the notes). Cost has yet to be confirmed but it is possible to register to receive further details in regard to future availability.
Dexcom G7 Receives CE Mark –
Next-Generation Continuous Glucose Monitoring System
to Revolutionize Diabetes Management
- The best-selling real-time CGM in the world1 is now more powerful and easier to use with a small, all-in-one wearable and completely redesigned mobile app
- New system has the fastest sensor warmup on the market,* with no fingersticks† or scanning required
- Dexcom G7 builds on the trusted performance of Dexcom CGM, which is clinically proven to lower A1C, reduce hyper- and hypoglycemia, and increase time in range2,3
EDINBURGH, Scotland & SAN DIEGO--(BUSINESS WIRE)--DexCom, Inc. (NASDAQ:DXCM), the global leader in real-time continuous glucose monitoring for people with diabetes, announced today it has secured CE Mark (Conformité Européenne) for the Dexcom G7 Continuous Glucose Monitoring (CGM) System for people with diabetes in Europe age two years and older, including pregnant women.
“Over the past 20 years, Dexcom has been one of the leaders and pioneers in advancing real-time CGM technology”
Dexcom G7 offers a better way to help users gain greater control of their diabetes, so that they can manage it more confidently each day. Its low-profile, all-in-one wearable warms up faster than any other CGM on the market,* sending real-time glucose readings automatically to a compatible smart device‡ or receiver, no fingersticks required.† Dexcom G7 also offers a suite of customizable alerts that can warn of high or low glucose levels and help users spend more time in range.§,2 Industry-leading remote monitoring and reporting capabilities also allow users to stay connected with their loved ones and care teams anytime, anywhere.||
“Today marks an incredible milestone for our company and for people with diabetes in Europe,” said Kevin Sayer, chairman, president and CEO of Dexcom. “This all-new platform offers an incredibly powerful CGM that is simple to use, providing our users with insightful glucose data on one screen that helps them spend less time managing diabetes and more time doing the things they love. Dexcom G7 takes everything people love about G6 and makes it even better.”
Dexcom is also working closely with its insulin pump partners to integrate Dexcom G7 into current and future automated insulin delivery systems as quickly as possible.
“Over the past 20 years, Dexcom has been one of the leaders and pioneers in advancing real-time CGM technology,” said Professor Partha S. Kar, OBE, national specialty advisor, Diabetes at NHS England and consultant endocrinologist at Portsmouth Hospitals NHS Trust. “With enhanced features and added simplicity, Dexcom G7 will hopefully make diabetes management easier for both patients and their healthcare providers, something that is especially important as we see more and more evidence of the benefits of CGM in broader populations of those living with diabetes.”
Dexcom expects to initiate a launch of Dexcom G7 in Europe in the next several weeks. The company also plans to introduce an updated CGM algorithm in 2022, driving the next step forward in CGM sensor performance.
Visit Dexcom.com and get started with Dexcom G6 today to experience the benefits of CGM now. To learn more about Dexcom G7 and for additional information about when it will be available in Europe, visit Dexcom.com/G7.
Dexcom submitted a comprehensive 510(k) pre-market notification to the U.S. Food and Drug Administration for regulatory review of the Dexcom G7 CGM System in accordance with the iCGM Special Controls in Q4 2021.††
About DexCom, Inc.
Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, and with operations across Europe, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world. For more information about Dexcom CGM, visit www.dexcom.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements that are not purely historical regarding Dexcom’s or its management’s intentions, beliefs, expectations and strategies for the future, including statements with respect to timing of the G7 launch in Europe, updates to its CGM algorithm and impacts to diabetes management. All forward-looking statements and reasons why results might differ included in this press release are made as of the date of this release, based on information currently available to Dexcom, deal with future events, are subject to various risks and uncertainties, including risks and uncertainties relating to our development, preparation, and potential future submission of a 510(k) application for G7 to the US FDA and the potential timing or results of regulatory review of such an application, and actual results could differ materially from those anticipated in those forward-looking statements. The risks and uncertainties that may cause actual results to differ materially from Dexcom’s current expectations are more fully described in Dexcom’s Quarterly Report on Form 10-Q for the period ended September 30, 2021, as filed with the Securities and Exchange Commission on October 28, 2021. Except as required by law, Dexcom assumes no obligation to update any such forward-looking statement after the date of this report or to conform these forward-looking statements to actual results.
*Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer.
†If your glucose alerts and readings from Dexcom G7 do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions.
‡To view a list of compatible smart devices, visit dexcom.com/compatibility
§Results obtained with a prior generation Dexcom CGM System.
||Separate Dexcom Follow app and internet connection required. Internet connectivity required for data sharing. Users should always confirm readings on the Dexcom G7 app or receiver before making treatment decisions.
¶Compared to a prior generation Dexcom CGM System.
#Healthcare providers can register for Dexcom Clarity at clarity.dexcom.com/professional/ registration.
**An internet connection is required for patients to send their glucose data to Dexcom Clarity via a compatible smart device: dexcom.com/compatibility. Healthcare providers will only be able to view a patient’s glucose data if the patient elects to share it with them through Dexcom Clarity.
††Pending 510(k) clearance -- Not available for sale in the U.S.
1 Dexcom, data on file, 2021
2 Beck RW, et al. JAMA. 2017;317(4):371-378.
3 Welsh JB, et al. Diabetes Technol Ther. 2019;21(3):128-132.
4 Dexcom G7 User Guide.