FDA Events for Neuronetics (STIM)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Neuronetics (STIM).
Over the past two years, Neuronetics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
NeuroStar. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
NeuroStar Advanced Therapy - FDA Regulatory Timeline and Events
NeuroStar Advanced Therapy is a drug developed by Neuronetics for the following indication: Anxious Depression.
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:
- NeuroStar Advanced Therapy
- Announced Date:
- September 16, 2024
- Indication:
- Anxious Depression
Announcement
Neuronetics, Inc. announced enhancements to its NeuroStar Advanced Therapy and proprietary TrakStar® patient data management software, introducing a range of new features aimed at improving patient communication, streamlining clinical data capture, and strengthening cybersecurity.
AI Summary
Neuronetics, Inc. has announced major upgrades to its NeuroStar Advanced Therapy system and its TrakStar® patient data management software. The enhancements introduce new features that improve the way practices communicate with patients, streamline clinical data capture, and strengthen cybersecurity. With automated SMS and email functions, clinicians can now offer personalized guidance during early treatment stages, while secure insurance card uploads help simplify claims processing and reduce manual errors.
Other updates include expanded survey options in the TrakStar system, allowing for automated clinical surveys that provide real-time patient insights. The NeuroStar device now synchronizes essential clinical data directly with TrakStar, enhancing accuracy and easing data collection. Additionally, proactive operating system updates ensure that patient information remains safe and encrypted. These improvements underline Neuronetics’ commitment to providing more efficient, secure, and personalized mental health care.
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Neuronetics FDA Events - Frequently Asked Questions
As of now, Neuronetics (STIM) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Neuronetics (STIM) has reported FDA regulatory activity for NeuroStar Advanced Therapy.
The most recent FDA-related event for Neuronetics occurred on September 16, 2024, involving NeuroStar Advanced Therapy. The update was categorized as "Provided Update," with the company reporting: "Neuronetics, Inc. announced enhancements to its NeuroStar Advanced Therapy and proprietary TrakStar® patient data management software, introducing a range of new features aimed at improving patient communication, streamlining clinical data capture, and strengthening cybersecurity."
Currently, Neuronetics has one therapy (NeuroStar Advanced Therapy) targeting the following condition: Anxious Depression.
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:STIM) was last updated on 7/12/2025 by MarketBeat.com Staff
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