Nyxoah (NYXH) said Wednesday it has obtained an "approvable letter" from the US Food and Drug Administration for its Genio system, a neurostimulator device for the treatment of obstructive sleep apnea.
The letter signifies that the application for the system "substantially meets" the FDA's requirements, the company said.
"The FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review," Nyxoah said.
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