Nyxoah announces FDA approvable letter for Genio pre-market approval application
Nyxoah (NYXH) announced that the FDA has issued an approvable letter regarding the company’s pre-market approval application for the Genio ...
FDA Issues Nyxoah an Approvable Letter for its Genio® System
INSIDE INFORMATIONREGULATED INFORMATIONFDA Issues Nyxoah an Approvable Letter for its Genio® SystemMont-Saint-Guibert, Belgium – March 26, 2025, ...
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FDA Issues Nyxoah an Approvable Letter for its Genio® System
The Approvable Letter means that Nyxoah’s application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA ...