Utrecht, The Netherlands-based ViCentra aims to deliver high-quality, user-friendly solutions for people with diabetes. The system last year launched in a hybrid closed-loop automated insulin delivery system that uses the Dexcom G6 CGM.
Kaleido features pulse technology that provides continuous micro-dosing of insulin.
“We are proud to achieve CE certification under MDR for Kaleido,” said Frans Cromme, CEO of ViCentra. “This milestone reflects our commitment to deliver a small and reliable insulin pump for insulin delivery, allowing users to live life with confidence and style.”
Kaleido offers users options in terms of wearability and comes comes with two durable, rechargeable pumps, eliminating the need to dispose of the pump every three days, while the infusion set lasts for that three-day span. The design aims to integrate seamlessly into the user’s daily life.
Users can choose between a short tube for placement as a patch directly on the body or a longer tube for carrying the pump in the pocket. They can pause or take the pump off for intermittent breaks, too. ViCentra designed 10 bright color options as well, giving customers a more personal choice.
“Receiving CE certification under the EU MDR is a testament to our rigorous quality standards and dedication to user safety. The Kaleido insulin pump meets the highest regulatory requirements, ensuring that we provide a safe and effective product for those living with diabetes,” added Desire Santiago, director of regulatory affairs.
