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DexCom (DXCM) G7 Receives FDA Clearance: The Most Accurate Continuous Glucose Monitoring System Cleared in the U.S.

December 8, 2022 8:45 AM EST

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DexCom, Inc. (NASDAQ: DXCM), the global leader in real-time continuous glucose monitoring for people with diabetes, announced today the FDA has cleared the next-generation Dexcom G7 Continuous Glucose Monitoring (CGM) System for people with all Types of diabetes ages two years and older.

“There’s a reason Dexcom has the best-selling real-time CGM on the market,” said Kevin Sayer, chairman, president and CEO of Dexcom. “For more than a decade, we’ve pioneered generation after generation of sensing technology that consistently delivers improved accuracy, reliability and a simpler user experience, giving people greater control of their diabetes. When we set out to design G7, our goal was simple: to make the most powerful, easy-to-use CGM available for people with diabetes, whether they have Type 1 or Type 2. G7 delivers squarely on that promise. And now that it has been cleared by the FDA, we look forward to making G7 commercially available in the coming months.”

New features with Dexcom G7:

  • 60% smaller, all-in-one, discreet† wearable, easier to use with fewer components
  • 30-minute sensor warmup, 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
  • Indicated for wear on the back of the upper arm for ages 2 years and older or the upper buttocks for ages 2-17 years old
  • Smaller plastic components and packaging, resulting in less waste than the Dexcom G6 CGM System1

Dexcom G6 features included with Dexcom G7:

  • No fingersticks, scanning or calibration
  • Real-time glucose readings sent automatically every 5 minutes to a compatible display device*
  • Integration with the world’s largest connected CGM ecosystem (including Apple Watch, Garmin and other digital health apps)*
  • Remote monitoring, enabling users to share glucose data with up to 10 followers#
  • Proven Dexcom accuracy and performance5
  • Only CGM to offer a predictive low alert that can recognize potentially dangerous hypo-incidences before they occur

Dexcom is working closely with its insulin pump partners to integrate Dexcom G7 into current and future automated insulin delivery systems as quickly as possible.

Proven performance with easy-to-use, customizable features

With Dexcom G7, the most recommended CGM brand among patients6 and healthcare providers7 now offers a more powerful and easier to use system with a small, all-in-one wearable, completely redesigned mobile app and no fingersticks or scanning 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 The system features a predictive low alert that provides a 20-minute advance warning of potentially dangerous low glucose levels so users can act quickly to avoid a hypoglycemic event. This critical feature continues to be at the forefront of the Dexcom experience, with more than 52 million Urgent Low Soon alerts acknowledged – more than 11 million of those in the middle of the night.1 Users can also share information with loved ones and care teams anywhere, anytime through industry-leading remote monitoring and reporting capabilities.# These features, among others, helped Dexcom G7 earn recognition as a CES 2023 innovation awards honoree in the wearable technology, digital health category.

“The first thing that stood out to me when I started using the Dexcom CGM was how easy it was to use,” said Zac Harmon, a Dexcom Warrior and blues musician. “It’s small, non-intrusive and has been the biggest part of my diabetes journey. It feels like it was made just for me, so I can focus more on what’s really important in my life.”

With the most coverage,4 more users pay less for the #1 preferred CGM6,7

As diabetes becomes increasingly prevalent, it’s more important than ever for all people with diabetes to have access to the best care and technology.

  • Dexcom is the number one covered and most reimbursed CGM on the market4 with a third of patients with commercial coverage paying $0 out-of-pocket and the majority paying less than $40 per month††,8
  • Dexcom has three times more patients paying $0 than competing CGM systems8 and is currently reimbursed by more than 97% of private insurance1 as well as Medicare nationwide and Medicaid in 45 states
  • The recent proposed rule change from the Centers for Medicare and Medicaid Services to expand access to CGM for more people with diabetes, including those not on insulin therapy, has the potential to give millions more people in the US access to Dexcom CGM so they can more effectively manage their diabetes

“Dexcom G7 is so simple and easy to use that it should be prescribed to every person with Type 1 and Type 2 diabetes,” said Thomas Grace, MD, a primary care physician in Findlay, Ohio. “G7 isn’t just great for people with diabetes, it’s great for healthcare professionals as well. The integration of Dexcom Clarity into the mobile app provides easy access to retrospective insights about a patient’s glycemic management during in person or telehealth appointments. With its exceptional accuracy and ease of use, I’m confident G7 will be a game changer for my patients.”

Dexcom expects to initiate a US launch of Dexcom G7 in early 2023. To facilitate immediate access to G7 for as many users as possible, the company will have accessible cash pay options in place as the company transitions coverage availability for G7.

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 the US, visit Dexcom.com/G7.



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