FDA Events for LivaNova (LIVN)
This section highlights FDA-related milestones and regulatory updates for drugs developed by LivaNova (LIVN).
Over the past two years, LivaNova has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Aura6000. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Aura6000 - FDA Regulatory Timeline and Events
Aura6000 is a drug developed by LivaNova for the following indication: Obstructive Sleep Apnea.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Aura6000
- Announced Date:
- May 7, 2025
- Indication:
- Obstructive Sleep Apnea
Announcement
LivaNova PLC announced 12-month, top-line data from its OSPREY randomized controlled trial (RCT), evaluating outcomes with the aura6000™ System for the treatment of moderate to severe obstructive sleep apnea (OSA).
AI Summary
LivaNova PLC announced positive 12‐month top-line data from its OSPREY randomized controlled trial evaluating the aura6000™ System for treating moderate to severe obstructive sleep apnea (OSA). The study showed that 65% of patients in the treatment group responded to therapy, achieving at least a 50% improvement from baseline in their apnea-hypopnea index (AHI) and reaching an AHI below 20. At 12 months, the trial reported a 68% reduction in both the median AHI and oxygen desaturation index, highlighting significant and sustained improvements in patient outcomes.
The aura6000 System uses a unique form of neurostimulation called proximal hypoglossal nerve stimulation (p-HGNS), which employs six electrodes to reach the muscles controlling the airway. These encouraging results support the potential of this therapy as a promising treatment alternative for patients struggling with moderate to severe OSA.
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LivaNova FDA Events - Frequently Asked Questions
As of now, LivaNova (LIVN) has not received any FDA approvals for its therapy in the last two years.
In the past two years, LivaNova (LIVN) has reported FDA regulatory activity for Aura6000.
The most recent FDA-related event for LivaNova occurred on May 7, 2025, involving Aura6000. The update was categorized as "Top-line data," with the company reporting: "LivaNova PLC announced 12-month, top-line data from its OSPREY randomized controlled trial (RCT), evaluating outcomes with the aura6000™ System for the treatment of moderate to severe obstructive sleep apnea (OSA)."
Currently, LivaNova has one therapy (Aura6000) targeting the following condition: Obstructive Sleep Apnea.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:LIVN) was last updated on 7/10/2025 by MarketBeat.com Staff
