Yes. The SIBIONICS GS1 CGM system received the EU MDR CE certification in 2023.

The SIBIONICS GS1 sensor applicator adopts a dual-spring design, which, compared to the single-spring design, allows users to easily insert the sensor with faster speed and less pain. According to the SIBIONICS lab, sensor insertion process could be finished within 0.1 seconds, shorter than human neural response time(0.15-0.2 s), and the sensor insertion force is about 1/20 of that of other sensor applicators.

For an optimal glucose monitoring experience, we recommend that you wear it on the upper back of your arm(the fatty part of the arm).

The CGM sensor is waterproof and can be worn when bathing, showering, swimming, or exercising. However, the sensor must not be submerged deeper than one meter of water and must not be left in the water for longer than an hour.

Each GS1 sensor is designed to last for 14 days. After 14 days of use, you'll be prompted by the SIBIONICS app to replace the sensor with a new one.

The latest version of the SIBIONICS app will store the last 90 days of your glucose data. You can choose 7, 14, 30, or 90 days of glucose data to generate your AGP reports.