Summary: LuxCreo has partnered with EMA Sleep Inc to scale the manufacturing of a next-generation 3D-printed EMA oral appliance for sleep apnea. This partnership follows FDA 510(k) clearance for the device and the adoption of LuxCreo’s iLux Pro Dental platform, enabling same-day, … [Read more...]
EMA Recommends Melatonin Drug for Children with Neurogenetic Disorders
Summary: The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the use of Slenyto, a prolonged-release melatonin drug, to treat insomnia in children with neurogenetic disorders. Originally approved in 2018 for children … [Read more...]