– Actiste, the world’s first unified diabetes care device with eSIM technology for monitoring and treating insulin-dependent diabetes, has received two CE marks.
– The EC certifications allow the company to move forward with its ongoing market entry and sales activities in the company’s primary target markets in the Middle East and Southeast Asia and opens up for future sales in over 30 European countries, where Sweden is most imminent.
– The development of the Actiste device was initiated in 2015. In June 2019, Brighter received ISO 13485 certification.
Actiste, the world’s first unified diabetes care device with eSIM technology for monitoring and treating insulin-dependent diabetes, has received not only one, but two, EC certificates (CE marks) from TÜV Rheinland (Notified Body). The collection of and feedback on valid real life health data will facilitate optimized and personalized diabetes management and contribute to the improvement of everyday metabolic control and enable behavioral change. Actiste is delivered as part of a subscription service; Actiste Diabetes Management as a Service.
Impact of CE Certification
The EC certifications allows Actiste to move forward with its ongoing market entry and sales activities in the company’s primary target markets in the Middle East and Southeast Asia and opens up for future sales in over 30 European countries, where Sweden is most imminent. The development of the Actiste device was initiated in 2015.
Diabetes demands smart treatment
According to the International Diabetes Federation (IDF), the total number of people living with diabetes will increase from 425 million to nearly 630 million over the next 20 years. The total number of insulin-requiring patients today is approximately 150–200 million people.
Using state-of-the-art eSIM technology, the device has a global out-of-the-box connectivity, making it completely independent of other devices to share health and treatment data. Actiste reduces the number of steps for daily diabetes care by up to 67% – from 28 steps to 9 – compared to other solutions on the market. Furthermore, Brighter’s patented technology enables unique logging of the actually injected doses and the possibility to track missed doses.
Actiste® Diabetes Management as a Service is a complete end-to-end service for people with insulin dependent diabetes. Initially, the company will focus on establishing the service in the Middle East, Sweden and Southeast Asia. According to the International Diabetes Federation (IDF), the total number of people living with diabetes will increase from 425 million to nearly 630 million over the next 20 years. The total number of insulin-requiring patients today is approximately 150–200 million people.
“The Actiste service can provide healthcare facilities and staff with new insights regarding the patients’ everyday life and treatment adherence. When it comes to chronic diseases, it is the time between the physical check-ups that is important, but today healthcare is lacking that information, leading to inefficient processes. They need valid data forming the basis for better and more efficient treatments,” says Henrik Norström, CEO Brighter.
