Business Wire

Dexcom G7 Receives CE Mark – Next-Generation Continuous Glucose Monitoring System to Revolutionize Diabetes Management

Share

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.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220309005998/en/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

With Dexcom G7, real-time glucose readings are sent automatically to a compatible display device. (Photo: Business Wire)

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.”

New features with Dexcom G7:

  • 60 percent smaller, all-in-one, discreet wearable, developed in partnership with Verily
  • 30-minute sensor warm up, fastest of any CGM on the market*
  • 12-hour grace period to replace finished sensors for a more seamless transition between sessions
  • Redesigned and simplified mobile app with Dexcom Clarity integration#,**
  • Improved alert settings for enhanced discretion
  • Redesigned optional receiver that is smaller, with a more vibrant, easier to read display
  • Direct to Apple Watch (anticipated future software release)

Dexcom G6 features included with Dexcom G7:

  • No fingersticks, scanning or calibration
  • Real-time glucose readings sent automatically to a compatible display device
  • Indicated for wear on the back of the upper arm and abdomen for ages 2 years and older or the upper buttocks for ages 2-17 years old
  • Integration with the world’s largest connected CGM ecosystem
  • Remote monitoring, enabling users to share glucose data with up to 10 followers||
  • Proven Dexcom accuracy and performance4

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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Media Contact
James McIntosh
619-884-2118
james.mcintosh@dexcom.com

Investor Contact
Sean Christensen
858-203-6657
sean.christensen@dexcom.com

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

flatexDEGIRO Starts Into Expected Record Year 2024 With a Jump in Revenues and Earnings25.4.2024 20:19:00 CEST | Press release

flatexDEGIRO starts into expected record year 2024 with a jump in revenues and earnings Revenues increased by 25% to € 123 million (Q1 2023: € 98 million) flatexDEGIRO benefits from both rising interest income and a significant increase in commission income per transaction EBITDA improves by 177% to € 54 million (Q1 2023: € 19 million) Consolidated net profit increases by 340% to € 30 million (Q1 2023: € 7 million) 121,000 new customer accounts in Q1 2024 increase customer base to over 2.8 million (March 2023: 2.5 million) Net cash inflows of € 1.8 billion in Q1 2024 Revenues and consolidated net income in 2024 expected to be at the upper end of the guidance corridor (revenue growth of 5-15% and increase in consolidated net income of 25-50%) For the first time, the Management Board and Supervisory Board will propose to the upcoming Annual General Meeting the authorization to buy back up to 10% of the share capital as well as an additional dividend of 4 cents per share Dr. Benon Janos,

OpenGate Capital Completes Sale of SMAC25.4.2024 19:14:00 CEST | Press release

OpenGate Capital (“OpenGate”), a global private equity firm, announced today that it has completed the sale of SMAC, a provider of waterproofing and building envelope systems, to Compagnie Financière Jousset (“CFJ”) and the SMAC management team. Terms of the transaction were not disclosed. SMAC was established in 1884 and has grown into a leader in the French waterproofing and facades market. OpenGate acquired the business in 2019 from Colas Group, a subsidiary of Bouygues SA. Following the carve-out and stabilization of SMAC in the first year of investment, OpenGate embarked on a three-prong approach to sell the manufacturing (“Industrie”) business lines in 2020 and 2021 and achieved the following results: March 2021: Axter (membranes business) was sold to IKO April 2021: Skydôme (skylights business) was sold to Kingspan January 2022: Résipoly (resins business) was sold to MAPEI After the disposals of the Industrie business lines, SMAC was then able to focus on its core “Travaux” (ins

Farcana Announces Gateway: Showdown - Playtest Kicks Off April 30th, with a 1,000,000 $FAR token prize pool!25.4.2024 17:40:00 CEST | Press release

Farcana, a highly anticipated competitive, team-based hero shooter, announces Gateway: Showdown, a public playtest event taking place from April 30th to May 4th, 2024. This playtest serves as a crucial opportunity for Farcana to gather valuable player feedback, showcase the latest iteration of the game before its official launch and offer players a chance to claim a portion of the 1,000,000 $FAR token prize pool. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240425936808/en/ Farcana Announces Gateway Showdown - Playtest Kicks Off April 30th, with a 1,000,000 $FAR token prize pool! (Photo: AETOSWire) Gateway: Showdown welcomes all aspiring heroes with a signup process designed for ease and accessibility. Players can visit the official Farcana website at https://www.farcana.com to download the game client, create an account, and be automatically enrolled in the playtest. Every match played during the event will contribute to

Antognolla at International Hospitality Investment Forum: Growing Interest in the Italian Market from Hotel Operators and Investors25.4.2024 16:39:00 CEST | Press release

Antognolla Resort & Residences joined world-class hospitality experts at the Hospitality Investment Forum EMEA (IHIF EMEA) on 15-17 April in Berlin. With over 2,500 attendees this year, IHIF EMEA remains one of the largest gatherings of industry professionals in the region. Hospitality experts and event participants reaffirmed the growing interest among hotel operators in Italy, evident from the number of prestigious international brands entering the Italian market. The hospitality market in the country is becoming more identity-driven, with the majority of hotel keys in the upscale and luxury category being branded. International operators are increasingly attracted to the country year by year: almost 70% of the properties in the pipeline will belong to international chains by 2026. Andrey Yakunin, Chairman of the Board of Directors of Antognolla Resort & Residences commented: “As international experts discussed during IHIF, identity-driven, branded projects are set to become the lead

Digital Transformation’s Next Era: Generative AI and Laserfiche 12 at 2024 Empower Conference25.4.2024 16:30:00 CEST | Press release

Preparing organizations for the next AI-driven phase of digital transformation is on the agenda at the 2024 Empower conference, hosted by Laserfiche — the leading SaaS provider of intelligent content management and business process automation — in Las Vegas through April 25. Laserfiche shines a spotlight on solutions that reduce complexity and accelerate information flow across the enterprise to help organizations manage increasing amounts of data. Empower attendees got an early look at the latest Laserfiche AI features, including Laserfiche AI Document Summarization. The new offering, powered by generative AI, eliminates tedious sifting through documents by generating concise summaries of documents containing either text or transcribed audio. Laserfiche AI Document Summarization, which represents one milestone in the Laserfiche AI vision to transform the workplace, will be available in the upcoming Laserfiche Cloud release on April 30, 2024. “At Laserfiche, we believe AI will impact p

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
HiddenA line styled icon from Orion Icon Library.Eye