FDA clears Dexcom G7 next-gen CGM
FDA clears Dexcom G7 next-gen CGM https://www.drugdeliverybusiness.com/fda-clears-dexcom-g7-next-gen-cgm/ Sean Whooley
Dexcom (Nasdaq:DXCM) announced today that the FDA cleared the next-generation Dexcom G7 continuous glucose monitoring (CGM) system.
FDA clearance for the highly anticipated device covers people with all types of diabetes aged 2 years and older.
San Diego-based Dexcom’s device features a 60% size reduction from the previous generation, the G6. It offers a 30-minute warmup period (down from waiting two hours for glucose readings to begin in the past).
G7 provides more information in one place with personalized insights, extended-wear design and more. It features a simple wear experience, starting with unscrewing a cap. The user then puts the sensor on their body and pushes a button. The device is then turned on and can be paired with a smartphone.
The Dexcom G7 demonstrated exciting results in glucose monitoring in a number of recent clinical trials. One study highlights its accuracy, and another demonstrates strong performance in pediatric users. Dexcom announced the international rollout of the next-generation Dexcom G7 CGM in October. The system won CE mark in March.
In order to pick up FDA clearance, Dexcom had to apply software tweaks based on FDA feedback earlier this year. This threw a wrench in the expected timelines for FDA 510(k) clearance and the subsequent U.S. launch.
New features of the Dexcom G7
Along with the size reduction, the discreet device offers improved ease of use with fewer components. The 30-minute sensor warmup marks the fastest of any CGM on the market Dexcom said. It also features a 12-hour grace period to replace finished sensors for a more seamless transition.
G7 also integrates with a redesigned and simplified mobile app. It has improved alert settings for enhanced discretion and an easier-to-read display. Users aged two and older can wear it on the back of the arm and those between two and 17 may wear it on the upper buttocks.
The new system also contains holdover features from the previous-generation G6. That includes no fingersticks, scanning or calibration and real-time glucose readings automatically sent every five minutes. It integrates with the CGM ecosystem, including Apple Watch, Garmin and other digital health apps. Remote monitoring with G7 allows for the sharing of glucose data with up to 10 followers.
“There’s a reason Dexcom has the best-selling real-time CGM on the market,” said Kevin Sayer, chair, 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.”
What’s next for G7?
Dexcom expects to initiate its U.S. launch for G7 in early 2023. It plans to offer accessible cash payment options to facilitate immediate access as it transitions coverage ability. The company previously said it is working with insulin pump partners on the G7, too. It plans to integrate the system into current and future automated insulin delivery systems as quickly as possible.
The company also noted that it remains the No. 1-covered and most reimbursed CGM on the market. One-third of patients with commercial coverage pay $0 out of pocket. The majority pay less than $40 per month, Dexcom said.
BTIG analyst Marie Thibault wrote that she expects coverage to build “rather quickly for those with access to G6 already.” She anticipated a rise in Dexcom’s share prices today.
DXCM shares were up more than 4% at $123.08 apiece near the close of trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up more than 7%.
A proposed local coverage determination (LCD) from CMS back in October could further bolster the G7. Analysts said the coverage, which expands CGM access, could represent a boost for Dexcom and other CGM makers.
“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 Dr. Thomas Grace, 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.”
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