FDA Issues Nyxoah an Approvable Letter for its Genio® System
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Nyxoah SA has received an Approvable Letter from the FDA for its Genio® system, a neurostimulation therapy for Obstructive Sleep Apnea (OSA). The letter indicates that the Pre-Market Approval (PMA) application substantially meets regulatory requirements, pending a final review of manufacturing facilities and methods. The company remains committed to bringing this innovative therapy to U.S. patients.
March 26, 2025 | 7:15 am
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The FDA's Approvable Letter suggests a positive trajectory for Nyxoah's market entry in the United States, with no further questions on clinical data or biocompatibility.
The Approvable Letter indicates strong potential for FDA approval, which could significantly boost Nyxoah's market prospects and investor confidence. No clinical or biocompatibility concerns were raised, suggesting a high likelihood of successful market entry.
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IMPORTANCE 90
RELEVANCE 100