Dexcom wins FDA nod for G5 CGM

Dexcom Inc. (NSDQ:DXCM) said today it won FDA pre-market approval for its G5 mobile continuous glucose monitor, the 1st approved monitor to send data directly to smartphones without a separate receiver.

The new glucose monitor, approved for ages 2 and up, will use a smartphone as the primary display and can send the data to up to 5 follower devices. The user and followers can remotely monitor the glucose information, set alarms and receive notifications based on the data.

Currently the app is only approved for use with Apple (NSDQ:AAPL) iOS devices, but San Diego, Calif.-based Dexcom said they expect approval for Google (NSDQ:GOOG) Android devices early next year.

“Dexcom is rapidly advancing technology for continuous glucose monitoring devices to improve diabetes management. Since January, the company has introduced the G4 Platinum CGM with Share, apps to enable the first CGM on the Apple Watch and now the Dexcom G5 Mobile CGM. These advances are making diabetes management more convenient and flexible than ever before. We are excited for the promise this new technology holds for patients and caregivers,” CEO Kevin Sayer said in a press release.

The new unit is slated to start shipping in late September, according to Dexcom.

“Obviously there are a lot of moving parts to our commercial launch plans given this sooner-than-expected approval, and the financial ramifications, such as inventory adjustments and revenue recognition policies are being evaluated and will be discussed in detail on the Q3-2015 earnings call in early November,” Sayer said in a prepared statement.

The approval came months before the company or analysts expected, Leerink Partners analyst Danielle Antalffy wrote today. Antalffy said the early arrival boosted their expectations for the year and served as a “key step in the evolution of DXCM’s CGM technology.”

The news has lifted shares 6.8% to $91.37 as of 12:15 p.m. EDT.

Antalffy said the company’s currently-in-development G6, with a likely longer wear time of up to 10 days and easier calibration scheme, would be the next big step for Dexcom. The analyst wrote that the company is hopeful for an early 2017 approval for the next-gen CGM.

Earlier this month, Dexcom said it signed a partnership deal with the life sciences team at Google to jointly develop continuous glucose monitoring products. The new partnership will bring together Google’s miniaturized electronics platform and DexCom’s sensor technology, and looks to develop next-generation CGM devices that will be less expensive than existing technologies, DexCom said.

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