FDA Events for Nevro (NVRO)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Nevro (NVRO).
Over the past two years, Nevro has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Nevro1™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Nevro1™ SI Joint Fusion System - FDA Regulatory Timeline and Events
Nevro1™ SI Joint Fusion System is a drug developed by Nevro for the following indication: In Comparison to Posterolateral and Lateral Approaches.
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:
- Nevro1™ SI Joint Fusion System
- Announced Date:
- November 18, 2024
- Indication:
- In Comparison to Posterolateral and Lateral Approaches
Announcement
- Nevro Corp. announced the publication of new data in Medical Devices: Evidence and Research, which demonstrate the superiority of the Nevro1™ SI Joint Fusion System ("Nevro1"), a posterior integrated transfixation cage system offering enhanced stability, minimized bone removal and increased fusion potential compared to a posterolateral cylindrical threaded single-implant system.
AI Summary
Nevro Corp has announced new clinical data published in Medical Devices: Evidence and Research that highlights the benefits of its Nevro1™ SI Joint Fusion System. This device is designed as a posterior integrated transfixation cage system and has shown superior performance compared to a posterolateral cylindrical threaded single-implant system. The study found that Nevro1 provides enhanced stability while minimizing bone removal and increasing fusion potential. These features may lead to more effective and robust joint fusion for patients suffering from chronic SI joint pain. Nevro1’s design is intended to improve patient outcomes by offering a less invasive approach with greater fixation strength, which could result in faster recovery and long-term relief. This data supports Nevro’s commitment to advancing innovative treatments in pain management and solidifying its role as a leader in the field.
Read Announcement
Nevro FDA Events - Frequently Asked Questions
As of now, Nevro (NVRO) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Nevro (NVRO) has reported FDA regulatory activity for Nevro1™ SI Joint Fusion System.
The most recent FDA-related event for Nevro occurred on November 18, 2024, involving Nevro1™ SI Joint Fusion System. The update was categorized as "Publication," with the company reporting: "- Nevro Corp. announced the publication of new data in Medical Devices: Evidence and Research, which demonstrate the superiority of the Nevro1™ SI Joint Fusion System ("Nevro1"), a posterior integrated transfixation cage system offering enhanced stability, minimized bone removal and increased fusion potential compared to a posterolateral cylindrical threaded single-implant system."
Currently, Nevro has one therapy (Nevro1™ SI Joint Fusion System) targeting the following condition: In Comparison to Posterolateral and Lateral Approaches.
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 (NYSE:NVRO) was last updated on 7/13/2025 by MarketBeat.com Staff