Ireland-based medical technologies provider Innovation Zed has secured the CE mark for InsulCheck DOSE add-on device, its single-unit add-on device for pen injectors.

The company has designed to automatically capture dose value dialled, injection event time stamp and temperature, along with mounting and unmounting events.

It collects the injection event data in real-time and automatically transfers the data to a compatible display device.

The regulatory certification indicates that the product meets relevant health, safety, and environmental requirements in the European Union (EU), said the company.

Innovation Zed CEO 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.”

Innovation Zed developed the InsulCheck DOSE, in collaboration with SHL Medical and its subsidiary SHL Technologies.

It was developed to meet the compatibility challenges associated with various injection pen designs and difficulties in working on a technology to support low-cost disposable pens.

According to the company, InsulCheck DOSE is a discreet add-on device that is compatible with all pen injectors to capture dose dialled, timestamp, ambient temperature, etc.

The convenient device comes with no buttons, no calibration requirements or interference with the normal injection process.

In addition, the add-on product comes with high-quality usability support features, including a vibrant OLED screen, which facilitates enhanced user engagement.

Innovation Zed intends to start the commercial launch of InsulCheck DOSE in Europe this year, with plans to roll out certain variations of InsulCheck DOSE over the coming years.

Minnock added: “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.”