Brighter has now obtained all outstanding medical device regulatory approvals in the United Arab Emirates
All of the outstanding medical device regulatory approvals for Actiste® Diabetes Management as a Service (the “Actiste Service”) have now been obtained in the UAE, which means that Brighter has now received all the regulatory approvals required to commercialize the Actiste Service in the country.
On Monday November 9 Brighter announced that the Company's pioneering diabetes management solution, Actiste®, has received market approval in the UAE, but that some additional regulatory approvals for certain consumables included in the Actiste Service offering were still outstanding.
About Actiste
Actiste is the world's first complete IoT care solution for monitoring and treating insulin-dependent diabetes. The unit brings together and combines all the necessary functions for diabetes care – blood sampling, blood glucose measurement and drug injection – in a single connected device.
The solution is based on patented technology for collecting data on specified biomarkers and injected volumes of drugs. With state-of-the-art eSIM technology, Actiste has global out-of-the-box connectivity, making it completely independent of other devices to utilize and share health and treatment data. Actiste received two CE-marks in September 2019 - one for MDD and one for IVDD.The Actiste device is delivered as part of a subscription service (“Actiste® Diabetes Management as a Service”). The service includes a digital platform for daily support and management, global connectivity, different levels of data sharing, continuous replenishment of consumables and enables coaching to continuously optimize and improve treatments. https://actiste.com.
For further information, please contact:
Investor Relations
IR@brighter.se
Henrik Norström, CEO
+46 733 40 30 45
henrik.norstrom@brighter.se
Certified Adviser
Brighter’s Certified Adviser is Eminova Fondkommission AB, +46 (0)8 – 684 211 10, adviser@eminova.se, www.eminova.se.
About Brighter AB (publ)
Brighter is a health-tech company from Sweden with a vision of a world where managing chronic diseases is no longer a struggle. We believe a data-centric approach is key to provide smarter care for chronic conditions. Our daily-care solutions facilitate the flow of real-life treatment data between chronic-disease patients, their loved ones and their care providers – improving quality of life, easing the burden on healthcare systems, and opening new opportunities for data-driven research. Brighter is certified under ISO 13485. In 2019 the company won the Swecare Rising Stars Award. The Company's shares are listed on Nasdaq First North Growth Market/BRIG.
This information is information that Brighter AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 10:02 CET on November 11, 2020.