LivaNova Secures FDA Approval for New Sleep Apnoea Device

LivaNova has received premarket approval from the U.S. Food and Drug Administration for its aura6000 system, a new treatment for moderate-to-severe obstructive sleep apnoea (OSA), with a planned launch in 2027.

The device uses hypoglossal nerve stimulation to treat OSA. Implanted under the skin, it detects breathing patterns and delivers electrical pulses that move the tongue forward, helping keep the airway open during sleep. It is designed for patients who cannot tolerate or do not benefit from CPAP therapy, the current standard treatment.

Approval was supported by results from the OSPREY trial, which showed significant improvements in sleep metrics, including a reduction in apnoea severity and oxygen desaturation levels. About 65% of patients responded positively to treatment.

With millions affected by OSA, this innovation offers an alternative for patients struggling with existing therapies, while LivaNova continues developing next-generation devices.

20-03-2026