Nyxoah Edges Closer to US FDA Approval for Genio

Nyxoah (NYXH) has released an update.

Nyxoah SA, a medical technology firm, has submitted the final module of its Premarket Approval application for the Genio system to the FDA, marking a significant step towards offering Genio to US patients with Obstructive Sleep Apnea. The Genio system, which is already CE marked in Europe for treating sleep apnea, is a battery-free hypoglossal neurostimulation therapy, and its approval in the US is anticipated by the end of 2024.

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