continuous glucose monitoring

By Jonah Comstock June 7, 2017
At long last, Dexcom's Share app, which allows users to view and share data from their G5 continuous glucose monitors, will be available for Android users. The Android app just now received FDA clearance, and the company will roll out the app this month. The launch is a long time coming: iOS users have had access to the app since 2015. “Providing Android users with access to the Dexcom G5 Mobile...
By Jonah Comstock December 20, 2016
The FDA has officially cleared the Dexcom G5 continuous glucose monitor to inform treatment decisions -- without the use of a fingerstick glucometer, other than for calibration. The G5 has been cleared for a while to complement a traditional glucometer, but this non-adjunctive clearance is the first of its kind according to Dexcom and the FDA, which both released statements.  "The FDA works hard...
By Brian Dolan June 6, 2016
Next month the FDA is hosting a public advisory committee meeting to discuss a change to the intended use of Dexcom's G5 Mobile Continuous Glucose Monitoring System (CGM) device that would allow the company to market the G5 as a CGM patients can base treatment decisions on. Currently, Dexcom's CGMs are considered adjunctive devices, which means they carry an asterisk that notes they are intended...
By Jonah Comstock May 25, 2016
Medtronic announced that it will work with Qualcomm Life to develop a new generation of smaller, affordable continuous glucose monitors (CGMs) for people with Type 2 diabetes, the companies announced today. Currently, CGM devices are mostly prescribed for people with Type 1 diabetes, while those with Type 2 are more likely to use discrete finger-prick glucometers. However, this new partnership...
By Aditi Pai May 11, 2016
Senseonics, a Germantown, Maryland-based company working on a longterm implantable continuous glucose monitor, has received a CE Mark for its Eversense Continuous Glucose Monitoring (CGM) System. “The CE Mark approval is a significant accomplishment for Senseonics as this application required rigorous regulatory review against high clinical and safety standards,” Senseonics CEO and President Tim...
By Jonah Comstock March 15, 2016
When the Apple Watch launched last year, Dexcom announced that it would have an Apple Watch app ready for its G4 continuous glucose monitor system, and it did. While users could see their CGM data on their wrist, that data had to go on a long trip to get there. With the G4, the implant sent data to a receiver box which sent data to the phone which sent data to the watch, and the user needed to...
By Jonah Comstock February 4, 2016
Germantown, Maryland-based Senseonics' Eversense continuous glucose monitor, which promises to be less invasive and longer lasting than traditional CGMs, still isn’t FDA cleared or CE-marked. But the company, which filed for an IPO last month, is pushing ahead on a partnership to maximize the user experience of its device, and to establish a pipeline for sending its data to users’ healthcare...
By Jonah Comstock January 14, 2016
Senseonics, a Germantown, Maryland-based company working on a longterm implantable continuous glucose monitor, has filed to go public with an IPO that, for now at least, is valued at $51.75 million.  Senseonics singular offering is a pill-sized sensor that is entirely implanted in the user’s upper arm so that it can continuously monitor their glucose levels. The device is meant to last at least...
By Jonah Comstock May 6, 2015
Dexcom was one of the first companies to announce that it would have an Apple Watch app, and a recent FDA guideline made it clear that, as a secondary display device for a cleared CGM, the Apple Watch app wouldn't require its own clearance. But users of other smartwatches, including the Pebble Watch and the Android devices have also had access to Dexcom CGM readings, just not through an...
By Jonah Comstock January 28, 2015
The Dexcom G4 receiver, which will have an "identical" form factor to the forthcoming Bluetooth version. In a call to investors days after its app won FDA approval, Dexcom CEO Kevin Sayer shared some of the company's follow-up plans for its new smartphone-connected continuous glucose monitor, including Android and smartwatch apps and apps that will run some analytics on the CGM data. Dexcom...