Irish R&D company Innovation Zed has secured CE mark for the InsulCheck DOSE add-on device, which is designed to automatically capture dialled dosage for insulin pen users.
The firm expects the CE Mark to pave the way for its commercial expansion within Europe.
The InsulCheck DOSE device also automatically captures injection event time stamps, temperature, and mounting and unmounting events. This data is automatically logged and sent to a compatible display device.
Compatible with all pen injectors, the add-on device has no buttons or calibration requirements and does not interfere with the regular injection process.
It enables high user engagement due to usability support features from an OLED screen.
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Innovation Zed CEO Dr Dean Minnock said: “InsulCheck DOSE is a third-generation product of the InsulCheck family and the most intelligent and compatible evolution of the InsulCheck platform.
“InsulCheck DOSE provides data that, when applied correctly, facilitates an evidence-driven approach to precision insulin management and significantly helps people with diabetes make more informed choices for their personal therapy plan.
“Our InsulCheck DOSE supports all insulin pens without changing the usability of the pen in any way and without interfering in the normal injection process. In securing the CE mark for InsulCheck DOSE we reached an incredible milestone for our company and for people living with diabetes in Europe.”
Through a partnership with SHL Medical and its subsidiary SHL Technologies, Innovation Zed has developed the InsulCheck DOSE with the aim of addressing the compatibility challenges of many injection pen designs.
The Irish firm is planning to launch the InsulCheck DOSE device on a commercial scale in Europe later in the year.
In the future, Innovation Zed plans to introduce variations on InsulCheck DOSE for new injection devices for several drug therapies.