Senseonics launches Eversense CGM System with non-adjunctive claim

Senseonics (NYSE:SENS) this week said it launched its Eversense continuous glucose monitoring system with its mobile app that can dose based on the system’s readings.

The Eversense System is a long-term, implantable CGM sensor that features a transmitter that sends discreet vibrations to alert users of low and high glucose levels. The system with the CGM mobile app can dose insulin based on system readings without the need for a confirmatory blood glucose finger stick measurement.

“We’re very pleased that the new Eversense app is available from the Apple App and Google Play stores, so now users in the United States can take full advantage of being able to make treatment decisions without the need to test their blood glucose levels. It’s a testament to the proven and robust Eversense technology that only a year after entering the U.S. market, we can enhance the user experience by providing this updated indication,” CEO Tim Goodnow said in a news release. “And with Eversense designated as a therapeutic CGM and payment decision from the Centers for Medicare and Medicaid was made, Medicare beneficiaries will soon be able to use Eversense CGM as part of their diabetes treatment plan in 2020.”

Senseonics’s Eversense CGM System features a fluorescence-based sensor, a smart transmitter worn over the sensor for data communication and a mobile app to display glucose values, trends and alerts. The sensor is inserted subcutaneously in the upper arm by a physician. With the non-adjunctive claim, the company says the system will still require 2 calibrations per day.

“Patients have expressed that many of the unique features of Eversense – its long-term use, removable transmitter, predictive alerts and on-body vibratory alerts – allow them to be more discreet with their diabetes treatment,” chief medical officer Francine Kaufman said. “Now, Eversense users also have the added benefit of not having to interrupt their activities to finger stick before taking insulin, eating or exercising. They can simply look down at their Eversense app and move on with their treatment decisions – providing them more flexibility throughout the day.”