www.fdanews.com/articles/201308-nyxoahs-investigational-sleep-apnea-system-gets-fda-approval-for-mris
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Nyxoah’s Investigational Sleep Apnea System Gets FDA Approval for MRIs
February 10, 2021
The FDA has approved revised labeling for Nyxoah’s investigational neurostimulation-based obstructive sleep apnea therapy, Genio, allowing patients implanted with the device to undergo full-body MRI scans.
With the approval, patients who receive the Genio system and those who previously received the implant can undergo full-body 1.5T and 3T MRI diagnostic scans within approved parameters.
The implant is being evaluated in a multicenter investigational device exemption (IDE) trial aimed at earning FDA clearance. The device received a marketing authorization from the European Commission in 2019.