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...
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...
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....
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...
February 4, 2019
Verily's prototype smart shoe. Verily is shopping for partners to develop a smart shoe with embedded sensors for movement, weight and fall monitoring, according to a CNBC report citing three anonymous sources. The company allegedly has a prototype design of the footwear that it has been showing off in private meetings, and is envisioning the shoe as a health product.
MRIs are A-OK. Senseonics’...
July 5, 2018
Interest in digital health is now sprouting up all over DC, from the president’s announcement of a new AI task force to FDA Commissioner’s shout out to digital health in his budget request.
In fact, the FDA is turning to developers in the digital health space to help solve some of the country’s most difficult problems. In May, the agency announced an innovation challenge aimed at tackling the...
June 22, 2018
At long last, Eversense, the implantable continuous glucose monitoring system from Senseonics, has received FDA clearance to be marketed in the United States.
“The FDA is committed to advancing novel products that leverage digital technology to improve patient care,” FDA Commissioner Dr. Scott Gottlieb said in a statement. “These technologies allow patients to gain better control over their...
February 21, 2018
Implantable glucose sensor company Senseonics has launched a remote monitoring app for its users in Europe, the Middle East, and Africa, where its CGM system is distributed by Roche.
The app, called Eversense Now, allows users of the sensor to select up to five friends or family members to view their glucose data, which is updated every five minutes. The feature is available for iOS users at the...
September 13, 2017
Today was a big day in the world of diabetes management technology, with major announcements from Abbott, Livongo, and Senseonics. Read on below for a round-up of diabetes news.
Livongo acquires Diabeto
Mountain View, California-based Livongo Health, the chronic condition management technology company founded by former Allscripts CEO Glen Tullman, has acquired Diabeto, a diabetes management...
August 11, 2017
As implantable CGM company Senseonics continues to wait for clearance from the FDA, the company isn't sitting on its hands. On a Q2 earnings call, CEO Tim Goodnow reported that the company continues to expand its operations in Europe, is close to a CE Mark for a longer-lasting second generation device, and is partnering with Roche and Type Zero on an artificial pancreas study with an eye on...