Nyxoah: FDA Issues Approvable Letter Regarding Pre-Market Approval Application For Genio System

(RTTNews) - Nyxoah SA (NYXH) announced the FDA has issued an Approvable Letter regarding the Pre-Market Approval application for the 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 FDAs PMA implementing regulations, and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review.

The company said the decision does not impact Genio's CE Mark or ongoing commercial activities in Europe.

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