LivaNova Receives FDA Premarket Approval For aura6000 System For Treatment Of Adult Patients With Moderate To Severe Obstructive Sleep Apnea

LivaNova PLC has received FDA premarket approval for its aura6000 System, the first hypoglossal nerve stimulation therapy approved in the U.S. without complete concentric collapse contraindication. The device is intended for adult patients with moderate to severe obstructive sleep apnea who have not responded to traditional therapies. A next-generation MRI-compatible version is expected to launch in the first half of 2027, pending further FDA review.