Mobia Medical (MOBI) FDA Approvals $11.99 -0.02 (-0.17%) As of 04:00 PM Eastern Add Share Share FDA Events Stock AnalysisAnalyst ForecastsChartEarningsFDA EventsHeadlinesInsider TradesSEC FilingsShort InterestTrendsBuy This Stock Mobia Medical's Drug in the FDA Approval ProcessThis 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. Publication - July 14,2026Publication Drug: VNS-REHABAnnounced Date: July 14, 2026Indication: Vivistim® Paired VNS™ TherapyAnnouncementMobia 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 SummaryMobia 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 Has Mobia Medical received FDA approval? As of now, Mobia Medical (MOBI) has not received any FDA approvals for its therapy in the last two years. What drugs has Mobia Medical submitted to the FDA? In the past two years, Mobia Medical (MOBI) has reported FDA regulatory activity for VNS-REHAB. What is the most recent FDA event for Mobia Medical? 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." What conditions do Mobia Medical's current drugs treat? Currently, Mobia Medical has one therapy (VNS-REHAB) targeting the following condition: Vivistim® Paired VNS™ Therapy. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Agios Pharmaceuticals FDA EventsAtossa Genetics FDA EventsBluejay Diagnostics FDA EventsCelldex Therapeutics FDA EventsCybin FDA EventsImmuneering FDA EventsInnate Pharma FDA EventsNektar Therapeutics FDA EventsACADIA Pharmaceuticals FDA EventsBelite Bio FDA EventsDogwood Therapeutics FDA EventsDyne Therapeutics FDA EventsEikon Therapeutics FDA EventsGreenwich LifeSciences FDA EventsHarrow FDA Events 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 Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:MOBI last updated on 7/15/2026 by MarketBeat.com Staff. 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Publication - July 14,2026Publication Drug: VNS-REHABAnnounced Date: July 14, 2026Indication: Vivistim® Paired VNS™ TherapyAnnouncementMobia 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 SummaryMobia 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
