Nyxoah’s Investigational Sleep Apnea System Gets FDA Approval for MRIs
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.