LivaNova gets FDA approval for sleep apnea device without collapse warning
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LivaNova Receives U.S. Food and Drug Administration Premarket Approval for aura6000 System to treat Moderate to Severe Obstructive Sleep Apnea
March 19, 2026 8:30 AM EDTFirst and only hypoglossal nerve stimulation therapy approved in the U.S. without complete concentric collapse contraindication or warning language
Next-generation, MRI-compatible device expected to launch in the first half of 2027, pending FDA supplement review
LONDON--(BUSINESS WIRE)-- LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced the U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) for the aura6000 System for the treatment of adult patients with moderate to severe Obstructive Sleep Apnea (OSA). The System utilizes proximal hypoglossal nerve stimulation... More
