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Diabetes patients could soon replace fingersticks with Senseonics implantable CGM

June 10, 2019 By Chris Newmarker

Senseonics - updated logoSenseonics (NYSE:SENS)  recently announced that the U.S. FDA has approved using the Eversense implantable continuous glucose monitoring (CGM) system as a replacement for fingersticks.

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.

Filed Under: Business/Financial News, Diabetes, Featured, Food & Drug Administration (FDA), mHealth (Mobile Health), Regulatory/Compliance Tagged With: Senseonics

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.

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