Diabetes care company Companion Medical revealed on Thursday the receipt of the CE mark for the InPen system, with expected launch in key international diabetic markets in Europe in 2019.
The company said the InPen system is commercially available by prescription in the US and is the only US FDA-cleared, smart insulin pen paired with an integrated diabetes management app. The app is available on the Apple App Store with launch in the Android marketplace expected later this year.
Like a traditional insulin pen, InPen has Bluetooth technology that connects to an easy-to-use smartphone app. InPen tracks each dose and delivers all of the data to the app on the smartphone. The app calculates doses, displays blood glucose and tracks insulin levels, storing up to a year of data.
In addition, the insights by InPen report displays aggregated glucose, insulin and meal data with detailed daily views, enabling providers to monitor glucose control and adherence patterns, identify the causes and effects of key decisions and make targeted improvements to therapy.
As the insulin pump therapy comprises less than 10% of US insulin delivery and even less in Europe, the company's advanced insulin and disease management technology for pen users fulfils a tremendous unmet need.
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