Posted by Michael Wonder on 14 Sep 2021
Nyxoah announces U.S. FDA breakthrough device designation granted for the Genio system for obstructive sleep apnea and complete concentric collapse
14 September 2021 - Nyxoah today announced that the U.S. FDA has granted the Genio bilateral hypoglossal nerve stimulation system breakthrough device designation for the treatment of adult patients with moderate to severe obstructive sleep apnea and complete concentric collapse of the soft palate.
The breakthrough designation is supported by data from the Company’s BETTER SLEEP trial, aimed at addressing the long-term safety and performance of the Genio system in adult patients with obstructive sleep apnea with and without complete concentric collapse.
