The Magazine for Sleep Professionals
Thursday, August 13, 2026
LivaNova PLC announced the U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) for the aura6000™ System for the treatment of adult patients with moderate to severe Obstructive Sleep Apnea (OSA). The System utilizes proximal hypoglossal nerve stimulation (p-HGNS), a differentiated neurostimulation modality, to treat OSA in patients with […]
Nyxoah SA has announced an important investment in Belgium to further scale its manufacturing capacity to support its continued growth in the United States and international markets. In addition to its existing contract manufacturing operations in the United States, the Company will expand its manufacturing footprint in Wallonia, reflecting Nyxoah’s […]
There’s no one-size-fits-all approach for managing sleep apnea. Continuous positive airway pressure (CPAP) has been the go-to treatment for almost 40 years, but doctors have realized that some patients are not able to tolerate a CPAP mask or keep up with CPAP treatment over time. If you have a moderate […]
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 […]
