Innovation Zed announced that it received CE mark approval in Europe for its InsulCheck Dose add-on device.
Dublin, Ireland-based Innovation Zed designed the InsulCheck Dose device as a single-unit add-on device for pen injectors. It automatically captures dose value dialed, injection event time stamps and temperature. The device also captures mounting and unmounting events.
According to a news release, the system logs real-time injection event data and sends it to a compatible display device. Innovation Zed said it also features compatibility with all pen injectors. The device has no buttons, calibration requirements or interference with the normal injection process. It also increases user engagement through high-quality usability support features from a vibrant OLED screen.
Innovation Zed said the regulatory nod “opens the door for commercial expansion” across the continent as the company grows. The company expects to begin a commercial launch of InsulCheck Dose in Europe this year. It also intends to introduce bespoke variations of the system to new injection devices for various drug therapies. Such expansions could come in the next few years.
“InsulCheck Dose is a third-generation product of the InsulCheck family and the most intelligent and compatible evolution of the InsulCheck platform,” said Innovation Zed CEO Dr. Dean Minnock. “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.”