Officials at the Germantown, Md.–based medical device company described the FDA approval for the non-adjunctive indication (dosing claim) as a major milestone. The company will make a new app available in coming months so that Eversense users can start taking advantage of the non-adjunctive dosing indication; they’ll still need to do two fingersticks a day under the new approval.
“The Eversense CGM will soon be used as a replacement to fingersticks to make treatment decisions. We expect this will allow our users to more conveniently and confidently live their lives with fewer interruptions,” Senseonics president and CEO Tim Goodnow said in a June 6 news release.
The FDA approval is also an important step toward Senseonics marketing the Eversense CGM to seniors because non-adjunctive labeling is the first requirement for Medicare coverage, according to Goodnow. Senseonics plans to explore opportunities with CMS to market Eversense to Americans who are 65 and older.
Senseonics launched Eversense in the U.S. in August 2018, about two months after it won FDA approval for the 90-day implantable CGM.
The Eversense CGM System includes a fluorescence-based sensor inserted subcutaneously into the upper arm, a smart transmitter worn over the sensor that facilitates data communication, and a mobile app displaying glucose values, trends and alerts.
Senseonics won another FDA approval in November 2018 that enabled nurse practitioners and physicians assistants — and not just trained physicians — the ability to implant and remove the Eversense device.
Senseonics in March announced the ability to integrate Eversense data into Glooko‘s diabetes data management tech.