Nyxoah Nears FDA Approval for Genio System

Nyxoah ( (NYXH) ) just unveiled an announcement.

On April 8, 2025, Nyxoah announced an update regarding the FDA approval process for its Genio system, a treatment for Obstructive Sleep Apnea. The FDA issued an Approvable Letter on March 26, 2025, indicating that Nyxoah’s application substantially meets regulatory requirements, pending a final review of manufacturing processes. Nyxoah is confident in addressing the remaining validation step at its U.S. manufacturing site and anticipates full approval in the second quarter, which would allow the company to launch the Genio system in the U.S. market.

More about Nyxoah

Nyxoah is a medical technology company specializing in the development and commercialization of innovative solutions for treating Obstructive Sleep Apnea (OSA). Their primary product is the Genio® system, a leadless and battery-free hypoglossal neurostimulation therapy designed to address OSA, a prevalent sleep disorder linked to increased mortality risk and cardiovascular issues.

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