Nyxoah Receives FDA Approval For Genio® System, A Wearable Neuromodulation Device To Treat Obstructive Sleep Apnea

The U.S. Food and Drug Administration (FDA) approved the Genio system, a new treatment by Nyxoah to treat obstructive sleep apnea (OSA). It is intended for use by people with moderate to severe OSA and an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65.;

"Today marks a defining moment for Nyxoah and for U.S. patients suffering from OSA. With the FDA’s marketing approval of the Genio system, we are proud to bring this innovative therapy to the U.S. market,” commented Olivier Taelman, Nyxoah’s Chief . . .