Senseonics has received FDA investigational device exemption (IDE) for its Eversense Gemini sensor, marking a significant milestone for the next-generation implantable continuous glucose monitor (CGM). An IDE allows a medical device company to conduct clinical trials on humans in the U.S. before the device has received full FDA approval. The company has already enrolled the first patients in the IDE trial and expects to complete enrollment in the second half of 2026.
Unlike the Eversense 365, Gemini is a self-powered and battery-enabled implantable CGM designed to reduce on-body hardware. The internal battery allows the sensor to collect glucose data without needing to wear transmitter at all times. Users can simply scan their smartphone over the implanted sensor using near-field communication technology to retrieve their readings.
The internal battery and can store up to eight hours of glucose data directly on the sensor. Gemini is being developed with three different usage modes. A continuous mode delivers real-time glucose readings every five minutes when the transmitter is worn. A scan-only mode allows users to go without a transmitter and check stored data when needed. And a flex mode would let users switch between those two options based on their preferences.
The Gemini news comes alongside additional momentum for Senseonics. The company recently received CE mark approval for its year-long Eversense 365 and launched an integration with Sequel Med Tech's twiist automated insulin delivery system in the U.S., expanding access for pump users looking for a long-wear CGM option. We’re having Senseonics and Sequel Med Tech on the podcast in the next few weeks, so if you have questions—drop them in the comments!
If clinical trials go as planned, Gemini could represent a meaningful shift toward more discreet glucose monitoring, offering users the flexibility of scanning on demand without a transmitter attached to their body.
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