January 21, 2020
One of the biggest digital health success stories of the two decades is in the diabetes space, especially the continuous glucose monitor (or CGM). The first CGM was approved by the FDA in 1999, but in the last decade we've seen CGMs become smaller, longer lasting and more comfortable, and we've seen huge strides in datasharing as CGM-phone connectivity went from novelty to commodity.
January 13, 2020
Dexcom’s G6 Continuous Glucose Monitoring system will soon be integrated with Livongo’s platform, thanks to a new partnership between the two diabetes-focused companies.
G6 users who are also Livongo members will be able to sync their device to the Livongo platform, which will be able to give users insights and health nudges about their behavior based on the CGM reading. The system will also be...
December 3, 2019
Dexcom continuous glucose monitor users and their caregivers found themselves in the dark this weekend when a key monitoring feature ceased to function with little to no warning.
The feature, called Dexcom Follow, transmits an alert when a CGM user’s blood sugar reaches a dangerous level and is often used by parents monitoring their children’s condition. When unexpected issues brought down the...
November 5, 2019
Type 1 diabetes management and CGM integration are now on the table for WellDoc’s BlueStar, a management platform well known for being the first mobile health product to secure reimbursement as a diabetes therapy.
Thanks to a new FDA clearance, the company’s seventh, BlueStar will include integrated glucose level insights related to food, medication and activity that are based on the data from...
November 4, 2019
The FDA has issued a class two device recall for Senseonics’ Eversense continuous glucose monitoring system. This posting follows a September notice from the company that alerted providers and distributors in the US that the sensors of certain devices may stop working prematurely.
Senseonics identified a small number of Eversense Sensors that have prematurely stopped functioning due to inadequate...
October 8, 2019
This morning the Dexcom G6 Pro Continuous Glucose Monitoring System got the greenlight from the FDA. The latest technology can gather real-time glucose data over a period of 10 days and has the ability to be switched to blinded mode or unblinded mode.
In blinded mode, patients don’t see their data automatically; instead, the clinician will get the data and then be able to discuss it with the...
August 9, 2019
In Dexcom’s latest earnings report, executives reported not only growing revenues and sales volume for the company, but a sense that the whole category of CGMs has arrived and is transforming diabetes care for the better, noting trends observed at the recent annual meeting of the American Diabetes Association.
“We have been on record for years telling that the future is ‘CGM First’ and we believe...
July 17, 2019
Following a major sales bump in the second quarter of 2019, Abbott Laboratories is planning to significantly ramp up manufacturing for its FreeStyle Libre continuous glucose monitoring system, the company shared during an investor’s call this morning.
Specifically, the company highlighted a 72.9% increase in organic sales growth during the three-month period, reaching a worldwide total sales...
June 7, 2019
Implantable CGM company Senseonics has received approval from the FDA for the non-adjunctive indication for its Eversense device.
Senseonics is only the third company to secure this indication, which allows a CGM to be used for insulin dosing in lieu of a fingerstick glucometer, though patients will still need to use fingersticks twice a day for calibration.
The company plans to go live with the...
May 20, 2019
On Friday, the FDA issued a warning to patients and providers describing the dangers of diabetes management devices and software that haven’t been assessed by the agency. These include any unapproved or unauthorized continuous glucose monitors, insulin pumps and automated insulin dosing systems, whether used as a standalone device or integrated as part of a glucose management system.