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LivaNova receives FDA premarket approval for CPAP alternative

March 23, 2026HME News Staff

LONDON – LivaNova has announced that the U.S. Food & Drug Administration (FDA) has granted premarket approval (PMA) for the aura6000 System for the treatment of adult patients with moderate to severe obstructive sleep apnea (OSA). The system uses proximal hypoglossal nerve stimulation (p-HGNS), a differentiated neurostimulation modality, to treat OSA in patients with an apnea-hypopnea index (AHI) between 15 and 65 and who have failed, do not tolerate or are ineligible for first-line therapies,...

CPAP Alternative, Food & Drug Administration (FDA), LivaNova, Obstructive Sleep Apnea (OSA)

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