• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy
  • Reports
    • Diabetes Technology Innovations Special Report
    • Continuous Glucose Monitoring (CGM) Market Report

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.

Shares of SENS fell 2.8% to $8.10 apiece in post-market trading today.

A look at the Senseonics fourth-quarter results

The Germantown, Maryland-based implantable long-term continuous glucose monitor (CGM) developer reported fourth-quarter revenues of $14.3 million for the three months ended Dec. 31, 2025. That marks 72.3% growth from the same three-month period a year ago.

Losses totaled $20.8 million, marking a 34.2% bottom-line slide, with losses per share totaling 46¢. That landed 3¢ behind expectations on Wall Street, although sales topped the estimates of $14.2 million in revenue.

Senseonics attributed its net loss primarily to increased expenses related to consignment sales and other costs related to taking over the commercialization and distribution of the Eversense CGM platform, which it officially took over from Ascensia on Jan. 1, 2026.

The company reported 103% new patient growth in the U.S. in 2025, driven largely by positive returns from direct-to-consumer (DTC) marketing efforts.

Senseonics expects full-year revenues to land between $58 million and $62 million. That would mark year-over-year growth of 65% to 76%. It accounts for the transition of Eversense commercialization and the company taking sales and marketing infrastructure in-house.

Commentary from President and CEO Tim Goodnow

“In 2025, we took strategic actions to set the company up for long term growth. Successfully bringing commercial operations in-house and investing heavily in DTC marketing, we built the foundations necessary to achieve the full potential of the world’s first and only year-long CGM. We delivered encouraging commercial results last year, and expect this momentum to continue. In 2026 we plan to expand Eversense 365 compatibility with AID systems, launch in Europe and complete the Gemini pivotal trial, an important milestone for our exciting innovation pipeline. These efforts, coupled with improved margins, set Senseonics up for continued strong performance this year and beyond.”

The analysts’ take

BTIG analysts Marie Thibault, Sam Eiber and Alexandra Pang maintain a “Neutral” rating for Senseonics. They point to potential improvements from bringing commercial activity in-house and a planned launch of Eversense 365 outside the U.S. beginning in the mid-second quarter.

The analysts say Senseonics expects the twiist integration launch to drive increased type 1 adoption. In addition to Eversense 365 and Gemini activity, they note that the company expects a 2028 launch for Freedom, its sensor that builds on Gemini with no on-body component and enhanced communication through Bluetooth.

Senseonics expects to spend between $12 million and $15 million on DTC efforts in 2026 to further spur growth. Management targets doubling its patient base from 2025 to 2026, the analysts said.

“We are encouraged by [Senseonics’] recent progress and look for more consistent execution with Eversense 365 as [Senseonics] oversees commercial efforts,” the analysts said. “Longer term, we want to see [Senseonics] find an eventual path toward profitability.”

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), MassDevice Earnings Roundup, Patient Monitoring, Regulatory/Compliance, Technology, Wall Street Beat Tagged With: Senseonics

IN CASE YOU MISSED IT

  • MiniMed wins CE mark for next-gen insulin pump, ups revenue guidance
  • Abbott wins FDA authorization for dual glucose-ketone sensor
  • FDA clears Roche’s Alzheimer’s blood test for rule-in and rule-out assessment 
  • MiniMed Flex now integrated with Abbot’s Instinct sensor 
  • Senseonics sees activist investor take a major stake

About Sean Whooley

Sean Whooley is an associate 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].

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.
MDO

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
About
Contact us
Listen to our Weekly Podcasts
Advertise

Copyright © 2026 · Arrowfly LLC. All Rights Reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of Arrowfly.

Privacy Policy | Terms & Conditions | RSS