Mobia Medical's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Mobia Medical (MOBI).
Over the past two years, Mobia Medical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
VNS-REHAB. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
VNS-REHAB FDA Regulatory Events
VNS-REHAB is a drug developed by Mobia Medical for the following indication: Vivistim® Paired VNS™ Therapy.
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:
- VNS-REHAB
- Announced Date:
- July 14, 2026
- Indication:
- Vivistim® Paired VNS™ Therapy
Announcement
Mobia Medical, Inc. announced the publication of two-year follow-up data from the VNS-REHAB study in Neurology®, the official peer-reviewed journal of the American Academy of Neurology.
AI Summary
Mobia Medical, Inc. announced that Neurology®, the official journal of the American Academy of Neurology, published two-year follow-up data from the VNS-REHAB study. The results show that Vivistim Therapy helped stroke survivors keep their upper-limb motor gains over time. These improvements also carried over into daily life, with participants reporting meaningful benefits in activity, participation, and overall quality of life.
The study also found positive three-year outcomes in 16 participants, adding more evidence that the therapy’s benefits can last. In some of the 49 total participants, scores improved even further between years one and two, suggesting recovery may continue with ongoing self-directed therapy. Together, the findings support Vivistim Therapy as a treatment that can deliver lasting and meaningful recovery for stroke survivors.
Read Announcement
Mobia Medical FDA Events - Frequently Asked Questions
As of now, Mobia Medical (MOBI) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Mobia Medical (MOBI) has reported FDA regulatory activity for VNS-REHAB.
The most recent FDA-related event for Mobia Medical occurred on July 14, 2026, involving VNS-REHAB. The update was categorized as "Publication," with the company reporting: "Mobia Medical, Inc. announced the publication of two-year follow-up data from the VNS-REHAB study in Neurology®, the official peer-reviewed journal of the American Academy of Neurology."
Currently, Mobia Medical has one therapy (VNS-REHAB) targeting the following condition: Vivistim® Paired VNS™ Therapy.
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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
FDA progress for NASDAQ:MOBI last updated on 7/15/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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