Two New CE Mark Approvals in the Europe Diabetes Market

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Roche Receives CE Mark for its Accu-Chek Solo Micropump System

Roche announced that it has received CE Mark for its Accu Chek® Solo micropump system. The company will initiate the pilot commercialisation phase for its innovative insulin delivery system in Austria, Poland, Switzerland and the UK in the coming weeks and is conducting a clinical study in several European countries.

“This important milestone will enable us to further expand access to insulin pump therapy to those people with diabetes who can benefit most from this therapy option – so they can spend more time in their ideal target range and experience an improved quality of life,” says Roland Diggelmann, CEO Roche Diagnostics. “The new modular design of our Accu-Chek Solo micropump system responds to the needs of people with diabetes for more discretion and flexibility.”

The Accu-Chek Solo micropump system allows for convenience and personalisation in insulin pump therapy while contributing to a more targeted and effective diabetes management. It offers the functionalities of a traditional insulin pump alongside with the technological advancement of tube-free insulin delivery. The system consists of two parts: a small, lightweight and semi-disposable insulin micropump and a fully-featured remote control incorporating blood glucose monitoring and bolus advice. The system provides bolus insulin dosing both from the remote control or directly from the pump as well as the option to detach and re-attach the pump without wasting insulin. In addition, the system connects to Roche Diabetes Care’s digital solutions such as the Accu-Chek Smart Pix system, providing decision and therapy support at the doctor’s office with a proven tool for efficient, effective and personalised diabetes management.


InPen Cleared in Europe to Make Insulin Injections Easier

Companion Medical, a company based in San Diego, landed the European CE Mark of approval for its InPen insulin management system. The InPen, which is already available in the United States, works like a common insulin pen, but also with the ability to send its usage data to paired smartphone. The data is used to help calculate future insulin dose recommendations, to keep one’s physician up-to-date on the patient’s compliance, and to help adjust therapy as necessary.

While the Insights app, that works with the InPen, recommends the dosage amounts, the user still has to manually input that setting on the pen before injections. This is an important safety feature, as it allows the patient to use the InPen even if the paired-up smartphone is not available.

The app creates a report that shows aggregated glucose, insulin, and meal data, on a day-by-day basis. The combination of all these relevant factors in one place can help to more easily identify any causes for abnormal glucose levels that can vary widely and often seemingly without reason.


For Further Information

More on the diabetes device market in Europe can be found in a series of reports published by iData Research entitled the Europe Market Report Suite for Diabetes Devices . The suite covers reports on the following markets: blood glucose meters, blood glucose test strips, lancets and lancing devices, continuous glucose monitoring (CGM), insulin, insulin pens, insulin syringes and insulin pumps.

The iData report series on diabetes devices covers the US and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about diabetes device market data or procedure data, register online or email us at for a Europe Market Report Suite for Diabetes Devices brochure and synopsis.

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