Everything you need to know about NeuroStar TMS Device Review 2026: Everything You Need to Know — how it works, what it costs, and how to find a provider who actually knows what they're doing.
The TMS Patient Buyer's Guide
Free 22-page guide — questions to ask, red flags, and how to choose the right provider.
What is NeuroStar?
NeuroStar TMS Therapy, made by Neuronetics, was the first TMS device cleared by the FDA for depression in the United States. It is a figure-8 coil system used to deliver repetitive TMS to the left dorsolateral prefrontal cortex.
FDA clearances
Per a published review of FDA milestones for TMS devices (FDA milestones timeline (PMC)) and Neuronetics’ announcements:
- 2008: Cleared for major depressive disorder in adults who had not achieved satisfactory improvement from prior antidepressant medication
- 2020: Intermittent theta burst stimulation (iTBS) added to the NeuroStar system, allowing shorter sessions
- 2024: Cleared as an adjunct treatment for adolescents ages 15 to 21 with major depressive disorder
FDA clearance applies to specific devices for specific indications. Ask your clinic which protocols and indications apply to its system.
Clinical evidence
The 2008 clearance was based on a multisite, double-blind, sham-controlled trial of 301 medication-free patients with major depression (O’Reardon et al., 2007). Active TMS outperformed sham on several depression scales and response rates were significantly higher with active treatment; the primary outcome analysis required a post hoc correction for baseline differences between groups.
A later multisite observational study of 307 patients treated in routine clinical practice reported a clinician-rated response rate of about 58% and a remission rate of about 37% at the end of acute treatment (Carpenter et al., 2012). That study was sponsored by Neuronetics, and observational data cannot be compared directly with controlled trials.
In a follow-up study of the same kind, about 62.5% of patients who had responded or remitted after the acute course still met response criteria through 12 months (Dunner et al., 2014).
Theta burst stimulation was shown to be non-inferior to standard 10 Hz rTMS in a large Canadian trial (Blumberger et al., 2018).
What a course looks like
Treatment is typically daily (five days a week) for about six weeks, followed by a taper. Standard sessions run roughly 19 to 37 minutes; iTBS sessions are much shorter. Before the first treatment, the clinician determines your motor threshold and treatment location.
Side effects and safety
The most common side effects are scalp discomfort at the treatment site and headache, which usually ease over the first week or so. Seizure is rare but serious, which is why clinics screen for seizure history, certain medications, and metal implants near the head.
Insurance
Most commercial insurers and Medicare cover TMS for treatment-resistant depression under specific criteria and with prior authorization; requirements vary by plan. See our insurance guides.
Questions to ask a clinic using NeuroStar
- Which protocol will you use for me, and how long are sessions?
- How do you measure my progress?
- Who is the supervising physician?
- What will my out-of-pocket cost be, in writing?
Use our clinic directory to find TMS clinics near you.
This article is for informational purposes only and does not constitute medical advice. Always consult with a qualified healthcare provider before starting any new treatment.
