Continuous glucose monitoring system maker Senseonics has won FDA approval for its Eversense E3, which can be used to measure glucose levels in adults with diabetes for up to six months.
The system works using a sensor that is implanted just under the skin by a healthcare provider. A transmitter worn over the sensor, on top of the skin, receives glucose data, provides vibratory alerts and...
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...
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...
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...
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....
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...
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.
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MRIs are A-OK. Senseonics’...
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...
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...
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...
