FDA & Government News

Sleep Apnea Device Receives FDA Approval

Randomized trial data support the approval, with sustained improvements in apnea severity observed.

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LivaNova PLC received FDA premarket approval for the aura6000 System, a hypoglossal nerve stimulation therapy targeting adults with moderate to severe obstructive sleep apnea who have not succeeded with other treatments. This device, the first of its kind in the US without strict contraindications, stimulates airway-controlling muscles to improve respiratory function. Supported by the OSPREY trial, results showed significant reductions in apnea-hypopnea index and improved patient outcomes. An advanced version is in development, aimed for a 2027 release.

Original Source(s)

Sleep Apnea Device Receives FDA Approval

  • by Kathryn Wighton

  • March 19, 2026

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