The Magazine for Sleep Professionals
Wednesday, May 6, 2026
Nyxoah SA has announced the DREAM U.S. pivotal study achieved a statistically significant reduction in the co-primary endpoints of 12-month AHI responder rate, per the Sher criteria, and ODI responder rate, both on an ITT basis. The DREAM study is a pivotal trial being conducted under an investigational device exemption […]
Today, Inspire Medical Systems, Inc. announced certain preliminary, unaudited results for the fourth quarter and full year that ended December 31, 2023, and provided its initial full-year 2024 guidance. Preliminary, Unaudited Fourth Quarter and Full Year 2023 Revenue and Recent Business Highlights Revenue for the fourth quarter of 2023 is […]
Inspire Medical Systems, Inc. has reported financial results for the quarter ended September 30, 2023. Recent Business Highlights Generated revenue of $153.3 million in the third quarter of 2023, a 40% increase over the same quarter last year Achieved gross margin of 84.1% in the third quarter of 2023 Reduced loss […]
Nyxoah SA today announced that the Company has entered into a partnership with ResMed Germany to increase OSA awareness and therapy penetration in the German market. Nyxoah and ResMed Germany will establish a continuum of care that will educate and guide OSA patients in the German market from diagnosis through treatment. […]
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 […]
Inspire Medical Systems, Inc. announced today that it has received approval from the Food and Drug Administration (FDA) to offer Inspire therapy to pediatric patients with Down syndrome. “Since our first FDA approval in 2014, the research team at Mass Eye and Ear, led by Dr. Christopher Hartnick, have pioneered […]
LivaNova PLC has announced the first patient implanted in the investigational device exemption (IDE) clinical study, “Treating Obstructive Sleep Apnea using Targeted Hypoglossal Neurostimulation” (OSPREY). The randomized controlled trial (RCT) seeks to demonstrate the safety and effectiveness of the LivaNova aura6000™ System, an implantable hypoglossal neurostimulator intended to treat adult patients with […]
Inspire Medical Systems, Inc. is providing an update on the 2022 Reimbursement payment rates for Inspire procedures performed in Ambulatory Surgical Centers (ASCs). The Centers for Medicare and Medicaid Services (CMS) today published updated addendum files for the 2022 ASC payment system, including updating the assigned device offset percentage and […]
Chief polysomnographic technologist David Moore recently became the first sleep disorders tech in the world to be fully certified in the Inspire Care Pathway, which is a set of best practices that guide use of the Inspire upper airway stimulation device that is implanted to treat sleep apnea. The UAB […]
Two-incision approach reduces average procedure time by approximately 20 percent Inspire Medical Systems, Inc. has announced receipt of U.S. Food and Drug Administration (“FDA”) approval for an improved surgical implant procedure that eliminates one incision with a revised placement of the pressure sensing lead. This newly approved procedure will reduce […]
