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.
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