Dexcom’s G6 CGM System Receives CE Mark

The road to global expansion and commercialization with any medical device company in the European Union (EU) depends on receiving the CE mark.  

On Tuesday (June 12), DexCom’s (NASDAQ:DXCM) G6 CGM continuous glucose monitoring system (CGM) received CE (European Commission) mark. The device will be available in the UK and Ireland sometime in June and is expected to launch in other European countries later this year.

The device is for diabetes patients ages two years and up, which features customisable alarms and alerts to warn the user of glucose levels—even while they’re asleep—an extended 10-day sensor for 43 percent longer wear, and a 28 percent lower profile than the previous generation.

“Not only does the product eliminate the need for fingersticks, but it also maintains the performance, connectivity and accuracy that the diabetes community has come to expect from Dexcom CGM,” John Lister, DexCom’s general manager for Europe, the Middle East and Africa (EMEA) said in the release.

When it becomes available, New Dexcom patients can order the device while current users can upgrade the Dexcom G6 system to include the new transmitter and sensors.

This product has revolutionized the way diabetics monitor their glucose and is an unparalleled device while accompanied with its own app. Through the app, users can share their glucose information with up to five people. This is very beneficial for young children in school as parents or caregivers can monitor a child’s glucose levels before the child is able to.

The Dexcom G6 is a stand-alone CGM system for multiple daily injection (MDI) users–a big concentration of type 1 diabetes patients–and can also be used by insulin pump therapy patients. The sensor measures glucose levels through the fluid in the tissue, which is changed every 10 days.

The US-based company founded in 1999 now has users in 39 countries around the world to transform diabetes care and management through CGM technology.

Investor takeaway

Since Tuesday’s announcement, DexCom’s share price increased 3.97 percent to US$98.78 percent.

Piper Jaffray analyst JP McKin reiterated a “buy” position for the company on Tuesday with a $116 price target—the highest over any other analyst in the past six months, according to TipRanks.

Investors interested in Dexcom’s device or share price can look forward to more European countries launching the product later in the year and the UK and Ireland launching later this month.

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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.