FDA approves first self-contained, mobile continuous blood glucose monitor from Dexcom

Sensor (1), transmitter (2), and a smartphone showing glucose data (3) -- Courtesy of Dexcom

Dexcom ($DXCM) had put a bit of a Band-Aid on its mobile strategy--its prior smart device-compatible continuous glucose monitor required a separate worn transmitter and a dedicated handheld receiver. But now the FDA has approved the first CGM system, dubbed G5, which connects an all-in-one adhesive sensor/transmitter combo directly to an app on a smart device.

The new system will launch in late September with initial compatibility with Apple's iOS; Android compatibility is slated for early next year. In the G5 iteration, there is no additional hardware to facilitate the wireless data transfer between the adhesive CGM and Dexcom's Share analytical and data sharing app, although the system can be used with a dedicated receiver instead of a smart device if the user opts to do so.

"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," said Dexcom President and CEO Kevin Sayer in a statement.

The G5 system is a big leap forward in terms of simplicity and ease-of-use for diabetic patients. The FDA approved it for adults as well as children as young as two-years-old. Dexcom has always had an edge with younger patients, who are most receptive to cutting-edge technology and whose parents require a way to remotely monitor glucose levels. The G5, like its predecessor, the G4, enables the user to share blood glucose data with up to 5 recipients, which can include healthcare providers as well as parents and other relatives.

But CGMs typically still require twice-daily calibration via the traditional finger-stick method. Up next, Dexcom expects to start to untether its CGM from the finger stick--it expects the G6 version will require only one calibration finger stick daily and enable 10-day extended wear. It hopes to start pre-pivotal testing for that newest iteration later this year, with a pivotal study planned for shortly after and a launch planned for early 2017.

Last fall, competitor Abbott Laboratories ($ABT) won a CE mark for its CGM that doesn't require daily finger stick calibration, the FreeStyle Libre. However, the company has yet to offer any guidance on its expectations or timing for an FDA review or a potential U.S. launch. The FreeStyle Libre requires a dedicated handheld reader to store blood glucose data.

Dexcom is trying to encourage G5 adoption among its existing customers by offering a free upgrade to the G5 for those that have ordered the G4 Platinum with Share System since the start of August. In addition, it's offering a "low cost cash upgrade" to the G5 for all patients who remain under warranty for their existing Dexcom CGM system.

Last week, Dexcom also did a deal with massive med tech entrant Google to develop a Band-Aid sized CGM that doesn't require finger sticks and is connected to the cloud.

Google ($GOOG) is no stranger to blood glucose monitoring technology. It did a deal last year with Novartis ($NVS) to develop blood glucose monitoring contact lenses--that product was heavily highlighted in Google's recently disclosed plan to reorganize. Google Life Sciences will be first division broken out under the new parent company Alphabet as a standalone company like the search-engine business Google.

- here is the statement