DexCom hasn’t been shy about its plan for opening up the CGM market by encouraging CGM use in a wider group of people with diabetes — including, eventually, people with Type 2 diabetes. On its second quarter earnings call, the company went deep on that focus on the future.
“More and more people with diabetes are adopting CGM that as the primary tool to manage their condition, especially as we...
It was good news for Dexcom in January when the Centers for Medicare and Medicaid Services announced they would reimburse for Dexcom’s — and initially only Dexcom’s — continuous glucose monitor. Now the rollouts to Medicare patients are starting, although the company isn’t exactly rolling in that government money. In fact, CEO Kevin Sayer said on a recent earnings call that they’ve yet to see a...
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...
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...
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...
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...
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...
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...
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...
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...
