Brighter - Approvals in the UAE and Saudi Arabia
Brighter recently announced that both the United Arab Emirates (UAE) Ministry of Health and Prevention (MOHAP) and the Saudi Food and Drug Authority (SFDA) have provided market approvals for the Actiste device. While all necessary regulatory approvals have been obtained in the UAE, commercialisation in Saudi Arabia will require additional regulatory approvals, such as for consumables, but those are expected to be granted in the coming months. Additional registration efforts are also underway in Malaysia, Singapore, Thailand and Indonesia and are about to start in Kuwait, Oman and Bahrain.Brighter publ AB is a Sweden-based company active in the healthcare sector. It is primarily engaged in the development of Brighter One, a self-care device dedicated for type 1 and type 2 diabetes patients. Brighter One integrates a lancet, blood glucose meter for test strips, dosing and injection mechanism, and storage of glucose level and dosing history data. The Company cooperates with partners such as Almi Foretagspartner AB and Innovationsbron, as well as a distributor Rubin Medical.
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