News & Press
Nyxoah's Final Hurdle for FDA Approval of Genio Neurostimulator for Sleep Apnea
Sleep Review Magazine4/9/2025·04/09/25🌐 Europe
Summary
Nyxoah received an approvable letter from the FDA for its Genio neurostimulator for obstructive sleep apnea, with only manufacturing process validation remaining. Genio is distinctive as a leadless, battery-free hypoglossal neurostimulator approved in Europe since 2019, including for complete concentric collapse patients contraindicated by competitors' devices.
Why it matters
Nyxoah's battery-free, leadless design represents a significant innovation in sleep apnea neurostimulation. As a European company (Belgium) that has achieved both CE Mark and near-FDA approval, Nyxoah demonstrates how European medtech can compete globally in the neurostimulation market.
#Neurostimulation#Sleep Tech#Europe#Industry
Want the full NeurotechMag Pro intelligence database?
Access 800+ papers, trials, patents, funding rounds and news items — updated daily.
Start free trialAlready a member? Sign in