September 21, 2020
Abbott announced that its Libre Sense Glucose Sport Biosensor has achieved a CE Mark, paving the way for a European roll-out.
The Libre Sense biosensor provides continuous glucose monitoring (CGM) to help athletes understand the efficacy of their nutrition choices on training and competition.
Based on Abbott's FreeStyle Libre technology for people living with diabetes, it is the first personal-...
August 11, 2020
Continuous glucose monitoring (CGM) system-maker Senseonics has cut a deal with Ascensia Diabetes Care and its parent company, PHC Holdings, outlining commercialization and distribution of the Eversense product line over the next few years.
According to the companies, Ascensia now holds exclusive global distribution rights for the Eversense, Eversense XL and future CGMs. The duration of the...
January 8, 2019
Ascensia Diabetes Care, the Swiss tech company originally formed a few years ago from a merger of Bayer Health’s diabetes division and Panasonic Healthcare, is officially moving into the CGM space via a partnership with Huzhou, China-based Zhejiang POCTech.
In the short term, the partnership will put an Ascensia-branded version of POCTech’s CE-Marked CGM in several markets by the end of the year...
October 5, 2017
AgaMatrix, the medical device that launched the first ever iPhone-connected glucometer, has secured a $32 million loan in order to reorganize the company into two distinct entities: AgaMatrix, which will continue to focus on Bluetooth-enabled glucometer's such as the company's newest Jazz Wireless 2 device, and WaveForm Technologies, which will be focused on the development of a proprietary...
September 7, 2017
Good news for anyone who thought Fitbit's move toward the smartwatch market would be a move away from health: The wearable maker has just announced a partnership with Dexcom that will bring data from the company's continuous glucose monitor directly to the display of Fitbit's upcoming Ionic smartwatch.
Athough Fitbit's have been used in the management of chronic diseases in a number of hospital...
August 3, 2017
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...
August 2, 2017
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...
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...
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...
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...