Avalon’s KangaLite Receives FDA 510(k) Clearance
Avalon Biomedical (Management) Limited (“ABM” or together with its subsidiaries, the “Group”) is pleased to announce that the Avalon Photonics’ KangaLite Phototherapy System has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the KangaLite in the United States. This allows Avalon’s customers to expand their neonatal care in the US. KangaLite has recently received the approval from China NMPA and CE mark in 2020.
KangaLite is designed to make the treatment of neonatal jaundice at home possible. It is a wearable phototherapy device which promotes kangaroo care as well as breast-feeding. More importantly, KangaLite offers an ideal option for home phototherapy during COVID-19 pandemic.