The Magazine for Sleep Professionals
Monday, September 28, 2026
Nyxoah SA announced that the first patient has been implanted in BREATHE, the Company’s U.S. post-approval study of the Genio® system. The procedure was performed by Rolando Molina, MD, otolaryngologist at South Florida ENT Associates. Edward Mezerhane, MD, FAASM, FACP, DABOM, CPI, sleep medicine physician at PharmaDev Clinical Research Institute […]
Recently published study results demonstrate the efficacy of LivaNova Plc’s aura6000 System in treating moderate to severe obstructive sleep apnea (OSA). Published in Annals of Internal Medicine, the full 12-month results from the company’s OSPREY randomized controlled trial (RCT) demonstrate the safety and efficacy of proximal hypoglossal nerve stimulation (pHGNS), a differentiated neurostimulation modality. Overall, the study authors concluded that pHGNS for OSA yielded clinically significant improvements versus […]
Inspire Medical Systems, Inc. participated in SLEEP 2026, the 40th annual meeting of the Associated Professional Sleep Societies (APSS) on June 14–17 in Baltimore, Maryland. SLEEP is the premier global forum for sleep medicine and research, jointly hosted by the American Academy of Sleep Medicine (AASM) and the Sleep Research […]
Nyxoah announced the pricing of an underwritten public offering in the United States, which includes shares sold in a private offering to certain qualified or institutional investors outside the United States, including within the European Union, of 55,232,558 of its ordinary shares at an offering price of $1.72 (EUR 1.48) […]
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 […]
Nyxoah SA announced that the U.S. Food and Drug Administration (FDA) has approved the Genio system (hypoglossal nerve stimulation) for a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65. Genio is […]
Although there are more than half a billion individuals worldwide affected by moderate to severe obstructive sleep apnea (OSA), the vast majority still remain undiagnosed and many are untreated.1-2 Healthcare in the United States is facing shortages at every level—and these shortages are projected to increase sharply over the next […]
Inspire Medical Systems, Inc. announced that two leading physicians in sleep medicine and sleep surgery, Paul T. Hoff, M.D., M.S., an otolaryngologist, and Ruchir P. Patel, M.D., F.A.C.P., a sleep medicine specialist, will join Inspire as Vice President and senior Medical Director, effective April 21 and June 2, respectively. “Dr. […]
Nyxoah SA, which develops breakthrough treatment alternatives for obstructive sleep apnea (OSA) through neuromodulation, announced an update on the FDA approval process for the Genio system. On March 26, 2025, the Company announced that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company’s Pre-Market Approval […]
