LivaNova wins FDA premarket approval for neuromod for sleep apnea

LivaNova (Nasdaq: LIVN)+ announced today that it received FDA premarket approval (PMA) for its aura6000 neuromodulation system for sleep apnea.

The system utilizes proximal hypoglossal nerve stimulation (p-HGNS), a differentiated neurostimulation modality. It aims to treat obstructive sleep apnea (OSA) in patients with an apnea-hypopnea index (AHI) between 15 and 65 who have failed, do not tolerate, or are ineligible for first-line therapies, such as positive airway pressure (PAP).

London-based LivaNova’s system could rival on-the-market neurostimulators from Inspire Medical and Nyxoah. They all offer an alternative to traditional CPAP sleep respiratory systems. LivaNova submitted the technology to the FDA in May 2025.

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