FDA Approves Eversense CGM for Non-Adjunctive Use

FDA Approves Eversense CGM for Non-Adjunctive Use

-Craig Idlebrook

Just ahead of the opening of the American Diabetes Association 79th Scientific Sessions, Senseonics has announced that the FDA has granted approval for the company’s Eversense continuous glucose monitor (CGM) to soon be used for blood sugar management without the need for separate confirming fingersticks.

The Eversense CGM joins Dexcom’s G5 and G6 and the Abbott Freestyle Libre Flash as the CGMs on the market which are FDA-approved for non-adjunctive use for blood sugar management. However, the Eversense CGM has the distinction of currently being the only implantable CGM available.

Currently, the Eversense CGM is approved by the FDA for up to 90 days of use in the United States, but Senseonics’ Eversense XL CGM is approved for up to 180 days of use in the European Union. The company is currently conducting trials to gain FDA approval for the XL in the United States.

In the announcement of the approval, Senseonics CEO Tim Goodnow pointed out that the non-adjunctive label is a key requirement for a CGM to receive Medicare coverage, hinting heavily that gaining such coverage will be a short-term priority for the company. Recently, the company announced it has worked with a distributor to gain an entry into the U.S. VA system.

The rollout of this new function will not require a new Eversense CGM to be implanted. However, current users technically will be required to download a new app that will be made available in the coming months to discontinue verifying fingersticks with the FDA’s blessing.

To read the full announcement, click here.

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