(RTTNews) - Senseonics Holdings, Inc. (SENS) a medical technology company has announced the completion of its CE Mark submission for the Eversense 365 Continuous Glucose Monitoring or CGM system, the world's first and only one-year CGM. The Eversense 365 system, approved by the U.S. FDA in September 2024 and launched in October 2024, is now one step closer to being available in the European Union or EU.
The submission, prepared under the EU Medical Device Regulation or MDR, will allow the commercialization of the system in several EU countries through Senseonics' commercial partner, Ascensia Diabetes Care.
The system is expected to be available in Germany, Italy, Spain, Poland, Switzerland, and Sweden following CE Mark approval.
Key Highlights:
-- Eversense 365 offers the longest-lasting CGM, staying active for an entire year, a significant improvement over traditional 10-14-day CGMs.
-- Benefits include consistent accuracy, minimal false alerts, and the ability to integrate with insulin pumps for automated insulin delivery systems.
Senseonics is optimistic about the future impact of Eversense 365 in Europe, building on its U.S. launch success and positive feedback from patients and healthcare providers.
The company plans to expand the availability of the system after CE Mark approval, aiming to enhance glucose control for people with diabetes across Europe.
Currently, SENS is trading at $1.00 up by 8.84%.
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