LivaNova Receives U.S. Food and Drug Administration Premarket Approval for aura6000 System to treat Moderate to Severe Obstructive Sleep Apnea
LivaNova PLC - Ordinary Shares (LIVN)
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Source: Business Wire
– First 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 (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, such as positive airway pressure (PAP).“FDA approval of the aura6000 marks a transformative moment for LivaNova and represents a major step forward f
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News
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LIVN
Earnings
- 2/25/26 - Beat
LIVN
Sec Filings
- 3/13/26 - Form 4
- 2/25/26 - Form IRANNOTICE
- 2/25/26 - Form 10-K
- LIVN's page on the SEC website