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CE mark for Eversense CGM

The Eversense Continuous Glucose Monitoring (CGM) System from Senseonics has been granted an EU CE mark approval. An implantable and long-term glucose sensor, the Eversense CGM eliminates the need for weekly sensor insertion.

Senseonics Holdings, Inc. has also signed an exclusive distribution agreement with Roche for the multi-country commercialization of the product. Under the terms of the agreement, Senseonics has granted Roche the rights to promote, market, and sell the Eversense product line to diabetes clinics and patients in Germany, Italy and the Netherlands.

“We are pleased to have Roche as our partner, and our distribution agreement represents an important step to enable expanded market access to our product,” said Tim Goodnow, CEO and President of Senseonics. “Roche Diabetes Care is a trusted and highly respected market leader with a broad customer base and deep knowledge of the needs of people with diabetes, and is ideally suited to market and commercialize the Eversense CGM System. Together with Roche’s market presence, and extensive sales and support network, we aim to deliver a truly innovative continuous, long-term glucose monitoring solution to millions of people with diabetes.”

Senseonics will retain responsibility for product development, regulatory approval, quality management, and manufacturing while Roche will be responsible for sales, marketing, customer support and distribution activities in Germany, Italy and the Netherlands. The distribution agreement may be expanded with additional products and territories in the future. However, in a separate deal, Senseonics is looking to commercialise the system first in Sweden in partnership with Rubin Medical. As yet, there is no date set for the UK to have the product available.

http://www.senseonics.com/

This news item first appeared in Desang Diabetes Magazine, our free-to-receive digital journal. We cover diabetes news, diabetes management equipment (diabetes kit) and news about food suitable for a diabetic diet. Go to the top of this page to sign up – we just need your email address.


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