The Magazine for Sleep Professionals
Friday, September 25, 2026
ProSomnus, Inc. announced plans to design a head-to-head clinical trial comparing its precision oral appliance therapy (OAT) and hypoglossal nerve stimulation (HGNS) in treating patients with severe OSA. The clinical trial plans follow updated results from the First Line Obstructive Sleep Apnea Treatment Study (FLOSAT), a prospective, independent, head-to-head, crossover […]
ProSomnus, Inc. announced the presentation of four abstracts at the 2023 American Academy of Dental Sleep Medicine (AADSM) Annual Meeting, held May 19-21 in Philadelphia, Pennsylvania, and two abstracts at the American Thoracic Society (ATS) 2023 International Conference, held May 19-24 in Washington, D.C. The data presented at both meetings […]
Nyxoah SA announced that the U.S. Food and Drug Administration (FDA) has approved the use of Nyxoah’s next-generation Genio® 2.1 system for use in the Company’s DREAM U.S. IDE pivotal study. Genio® 2.1’s upgrades are entirely related to the external components of the Genio® system, as the implantable stimulator remains […]
Nyxoah SA has announced that the U.S. Food and Drug Administration has granted the Genio® bilateral hypoglossal nerve stimulation system Breakthrough Device Designation for the treatment of adult patients with moderate to severe OSA and Complete Concentric Collapse (CCC) of the soft palate. The FDA’s Breakthrough Designation Program was created […]
