Nyxoah SA, makers of a European Union CE-validated neurostimulator for obstructive sleep apnea that is working on getting US Food and Drug Administration (FDA) approval, has received CE Mark magnetic resonance imaging (MRI) conditional labeling for its Genio neurostimulation-based system.
This revised labeling means patients who receive the Genio bilateral stimulation therapy and those already implanted can now undergo full-body 1.5T and 3T MRI diagnostic scans within approved parameters.
Olivier Taelman, Nyxoah CEO, says in a release, “We are delighted to announce full-body 1.5T and 3T MR conditional CE mark approval for the Genio system, resulting from the unique and unparalleled design of our technology. Such an extensive labeling is unique to Nyxoah in the field of neurostimulation-based OSA therapies. Currently other therapies cannot fully address this need due to limitations to 1.5T MRI scans and body areas exclusion. As a company, Nyxoah always puts the patient first and seeks to ensure minimal disruption of their daily life and optimal quality of life.”
Clemens Heiser, MD, MHBA, PhD, ENT surgeon from Klinikum Rechts der Isar – Munich, says in a release, “Prevalence of MRI scans as diagnostic modality is growing, especially for OSA patients, as this condition is being associated with increased risk of comorbidities, such as cardiovascular diseases. The addition of 1.5T and 3T full-body MR conditional labeling for the Genio system will be another critical benefit for my patients and will help me ensure those who may need an MRI can benefit from Nyxoah’s innovations with no fear for themselves and their implant during the exam.”