Senseonics wins another FDA approval for its implantable CGM

Senseonics (NYSE:SENS) said this week that it won another FDA approval for its implantable continuous glucose monitoring system, giving nurse practitioners and physicians assistants the ability to implant and remove the Eversense device.

When the product was first approved by the FDA in June, only trained physicians were allowed to conduct the sensor insertion and removal procedures.

Senseonics’ Eversense device is the first CGM system to feature an implantable sensor that can be worn for up to 90 days.

The system includes a small sensor that is implanted just below the skin in an in-office procedure. It continuously measures glucose levels, sending that data to a mobile app every five minutes and alerting users if their glucose levels drop out of range. The company’s wearable transmitter can also be removed, recharged and re-adhered without discarding the implanted sensor, according to Senseonics.

“We are pleased with this FDA approval, we can now include nurse practitioners and physician assistants in the growing list of diabetes care professionals who can be certified to place the Eversense CGM System,” president & CEO Tim Goodnow said in prepared remarks. “We believe that allowing additional health care providers to perform the in-office placement procedure for Eversense CGM will enable broader access to patients for this compelling long-term diabetes management technology.”

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