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

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

March 2, 2026 By Sean Whooley

Senseonics Logo

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.

Other recent highlights include CE mark approval for the year-long Eversense 365, along with the launch of the CGM’s integration with the Sequel Med Tech twiist automated insulin delivery system in the U.S.

Get the full story at our sister site, Drug Delivery Business News.

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Health Technology, Implants, MassDevice Earnings Roundup, Patient Monitoring, Wall Street Beat Tagged With: Senseonics

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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