Senseonics earns FDA IDE for next-gen Gemini CGM, posts Q4 revenue beat

Senseonics (NYSE:SENS) posted fourth-quarter results that proved mixed compared to Wall Street forecasts alongside a major pipeline announcement.

Along with its fourth-quarter results, the company shared that it secured FDA investigational device exemption (IDE) for its self-powered, battery-enabled Gemini sensor. It enrolled the first patients in the IDE trial and expects to complete that in the second half of 2026.

With Gemini, the company wants to eliminate the transmitter aspect completely. The battery allows the sensor to collect data without the on-body transmitter component. Senseonics designed the Gemini system with existing near-field technology, allowing users to scan their smartphone over the sensor — which remains the same as with the Eversense system — to access their data.

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