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LivaNova (LIVN) FDA Events

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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.

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

  • 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
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