FDA Approves Nyxoah’s Genio® System for Treating Obstructive Sleep Apnea
On August 08, 2025, Nyxoah SA, a medical technology company that developed breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, announced that the U.S. Food and Drug Administration (FDA) had approved the Genio system for a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) between 15 and 65.
Genio represented a different approach to hypoglossal nerve stimulation (HGNS) for the treatment of OSA. Its unique design utilized bilateral stimulation and offered patients a leadless, full-body 1.5T and 3T MRI compatible, ...