CGM

By Dave Muoio 12:00 pm 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...
By Dave Muoio 02:26 pm 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...
By Laura Lovett 04:05 pm 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...
By Jonah Comstock 03:04 pm 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...
By Dave Muoio 03:23 pm 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...
By Jonah Comstock 02:41 pm 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...
By Dave Muoio 12:26 pm 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. “These...

Photo credit: Biolinq

By Laura Lovett 01:39 pm March 28, 2019
This morning Biolinq, a digital health company specializing in minimally invasive continuous glucose monitoring, raised $4.75 million in extended Series A financing. This new capital was led by JDRF T1D Fund, Aphelion Capital and LifeSci Venture Partners.  This latest funding announcement will build on the $10 million the company raised in November of 2017, bringing the total Series A capital to...
By Laura Lovett 02:47 pm March 25, 2019
On Friday, Senseonics, maker of the implantable continuous glucose monitoring system Eversense, announced a new program geared towards patients with high-deductible insurance plans or plans that don’t cover the full cost of the CGM.  The new program, called Eversense Bridge, charges patients $99 for the Eversense CGM system, in addition to the cost of the sensor placement by their provider....
By Laura Lovett 01:39 pm March 5, 2019
This morning Senseonics, an implantable glucose sensor company, announced that data from its Eversense continuous glucose monitor will be integrated into the Glooko diabetes management platform.  This means that users of the Eversense CGM and app will now be able to sync it with the Glooko online platform and app, and be able to see historical blood glucose-related data as well as get updates...