Strictly speaking, no: TMS devices are FDA-cleared, not FDA-approved. Every TMS device is a Class II medical device, and FDA reserves the word "approval" for the higher-risk Class III devices that go through premarket approval. Clearance is still a real FDA review. It means FDA has authorized a specific device for a specific use, and TMS has been cleared for major depression in adults since 2008.
Today, cleared uses include adult depression (including depression with anxiety symptoms), OCD, smoking cessation, depression in 15- to 21-year-olds as an add-on to medication, PTSD as an add-on, and migraine with a separate type of device. Anything else, including bipolar depression, anxiety on its own and ADHD, is off-label.
Cleared, approved and De Novo: what the words mean
FDA uses three main routes for medical devices, and the vocabulary is specific:
- 510(k) clearance. The maker shows the device is "substantially equivalent" to one already legally on the market. The result is that the device is "cleared". Most TMS devices reached the market this way.
- De Novo. A route for a new kind of device with no existing equivalent; the result is "De Novo granted". The first depression system (NeuroStar, 2008), the first migraine device and the first OCD device came through De Novo.
- Premarket approval (PMA). The strictest route, for Class III devices. This is where "FDA-approved" correctly applies to a device. No TMS device holds a PMA.
Drugs are different: they are "approved". For example, Spravato (esketamine) nasal spray, a drug used for treatment-resistant depression, was FDA-approved in March 2019. So if a clinic calls a TMS device "FDA-approved", it is using loose language. Even Medicare's coverage policy uses the phrase "FDA-approved or -cleared". The bigger question is whether the use being offered is on a cleared label at all.
What TMS is cleared for: devices, conditions, years and ages
This table shows the first clearance for each use and a few later milestones. It is not a complete list of every device; several manufacturers now hold similar clearances.
| Use | Device (first or notable) | Year | Ages on the label | Notes |
|---|---|---|---|---|
| Major depression | NeuroStar | 2008 | Adults | De Novo; first TMS system for depression |
| Major depression (deep TMS) | BrainsWay H-coil | 2013 | Adults | 510(k) |
| Major depression, theta burst (iTBS) | MagVita (MagVenture) | 2018 | Adults | Sessions of about 3 minutes |
| OCD | BrainsWay H-coil | 2018 | Adults | Add-on treatment; later also MagVenture, NeuroStar and others |
| Smoking cessation | BrainsWay H-coil | 2020 | Adults | Aid to short-term quitting |
| Depression with anxiety symptoms | BrainsWay H-coil, then NeuroStar | 2021 | Adults | Anxiety symptoms alongside major depression |
| Accelerated depression protocol (SAINT) | Magnus Neuromodulation System | 2022 | Adults | 10 sessions a day for 5 days, MRI-guided target |
| Major depression, adolescents | NeuroStar, then six other systems by 2026 | 2024 | 15 to 21 | Adjunct: added to medication |
| Accelerated deep TMS (AcciTBS) | BrainsWay | 2025 | Adults | Spread over 6 weeks, not 5 days |
| Accelerated TMS, 2 to 10 sessions a day | MagVenture aTMS | 2026 | Adults | With or without MRI-based targeting |
| PTSD | Wave Neuroscience MeRT System | 2026 | Adults | Adjunct; first TMS-based PTSD clearance |
| Migraine | Cerena; later SpringTMS | 2013 | 12 and older (label expanded in 2019) | A separate device type, cleared for migraine rather than psychiatric use |
For a device-by-device comparison, including coil types and cleared protocols, see the physician's guide to TMS devices compared. Condition guides: TMS for OCD and TMS to quit smoking.
What the depression label actually says
The depression clearances are for adults whose major depression has not improved enough with antidepressant medication in the current episode. The 2008 wording was narrower, referring to one prior antidepressant at an adequate dose and duration. By 2016 the NeuroStar label had been broadened to "prior antidepressant medication" in the current episode, without the "one medication" wording. A 2018 expert consensus noted that FDA's labeling does not restrict TMS to people with only one medication failure.
You may also see the 2011 federal regulation quoted as saying TMS is for patients "currently not on any antidepressant therapy". That is legacy wording; later labels are broader, and the adolescent labels specifically require use alongside medication. Whether to continue antidepressants during TMS is an individual decision; see medications during TMS.
Note that FDA's label and your insurance plan's rules are separate. A plan may require more failed medications than the label does; see how many antidepressants you need to try before TMS is covered.
Age limits: adults, teens and children
Most TMS clearances are for adults. Since March 2024, TMS has also been cleared for major depression in people aged 15 to 21, but only as an adjunct, meaning added to medication rather than replacing it. By August 2026, seven systems carried that adolescent label.
Two details matter for families. The NeuroStar adolescent clearance relied on open-label registry data rather than a sham-controlled trial, and its age floor is 15 because only 10 patients in the data were aged 12 to 14. The one large sham-controlled trial of TMS in adolescents found no difference between active and sham treatment. TMS is not cleared for depression in children under 15. The full picture is in TMS for teens and young adults.
If you are thinking about suicide or are in crisis, call or text 988 (the 988 Suicide & Crisis Lifeline) or go to the nearest emergency room.
Accelerated TMS: which protocols are cleared
Accelerated TMS gives several sessions a day so a course finishes sooner. Three accelerated approaches are now cleared:
- SAINT (Magnus), cleared in 2022 through a 510(k), not De Novo: 10 sessions a day for 5 days with an individually chosen, MRI-guided target. FDA's summary notes that effectiveness was evaluated only up to four weeks after treatment.
- BrainsWay AcciTBS, cleared in 2025: 30 sessions over 6 treatment days within 2 weeks, then 8 more sessions; the whole schedule spans 6 weeks.
- MagVenture aTMS, cleared in 2026: schedules from 2 up to 10 sessions a day, with or without MRI-based targeting.
SAINT is therefore no longer the only cleared accelerated option. What is not cleared: single-day protocols that combine TMS with medications given beforehand. The Clinical TMS Society has stated that one such protocol, ONE-D, is not FDA-cleared and that its evidence does not yet meet the threshold to recommend it. The physician's guide covers the evidence in accelerated TMS: protocols, evidence and FDA status.
What "off-label" means, and common off-label uses
Off-label means using a cleared device for a condition, age group or protocol that is not on its label. It is legal for a physician to do this, and sometimes reasonable, but it means FDA has not reviewed evidence for that use and insurance often will not pay for it. Common off-label or research-stage uses include:
- Bipolar depression. Not cleared. A 2026 review reports an FDA "breakthrough" designation, which is a review designation, not a clearance.
- Generalized anxiety disorder on its own. Not cleared; evidence is low-strength. See TMS for anxiety.
- Depression during pregnancy or after birth. Not a specific cleared use; see TMS during pregnancy and postpartum.
- ADHD, autism, Alzheimer's disease, tinnitus and others. A 2020 European evidence-based guideline found definite evidence of efficacy (its Level A) only for depression, neuropathic pain and hand recovery after stroke. An FDA advisory panel found an Alzheimer's TMS system had not shown clinically meaningful benefit.
If a clinic offers an off-label use, it should say so plainly, explain the evidence, and tell you what it will cost if insurance does not cover it.
How to check a device's clearance yourself
You do not have to take a clinic's word for it. FDA's public 510(k) and De Novo databases list every clearance with its decision date and the exact "indications for use" wording. A few tips make the search easier:
- Ask the clinic for the device maker and model, for example "NeuroStar Advanced Therapy" or "BrainsWay Deep TMS".
- Search FDA's database by the company name rather than the brand name, since records are filed under the applicant.
- Open the most recent clearance summary and read the "indications for use" section. That sentence is the label: it names the condition, the age range and whether the device is used as an adjunct.
- Compare it with what you are being offered. If your condition, age or schedule is not in that sentence, the use is off-label.
Clearances change over time. Several important ones, including the adolescent, accelerated and PTSD labels, date from 2024 to 2026, so older articles online are often out of date.
What FDA clearance does and does not tell you
Clearance tells you FDA reviewed the device's safety and intended use. It does not tell you how well TMS will work for you, which protocol a clinic uses, or whether a given clinic is following the cleared schedule. It also does not mean every newer protocol has the same depth of evidence: SAINT's clearance, for example, rested on studies from a single site.
Questions worth asking any TMS clinic: which device and protocol will I receive, is it cleared for my condition and age, and if not, why do you recommend it? The TMS glossary defines terms you may hear, and what TMS therapy is covers the basics. Browse the full TMS patient guide or read about TMS therapy at the practice.
Sources
- Premarket Notification 510(k). U.S. Food and Drug Administration, 2026. fda.gov
- De Novo Classification Request. U.S. Food and Drug Administration, 2026. fda.gov
- Premarket Approval (PMA). U.S. Food and Drug Administration, 2026. fda.gov
- 21 CFR 882.5805 Repetitive transcranial magnetic stimulation system. eCFR, 2026. ecfr.gov
- De Novo Classification Request DEN070003 (NeuroStar TMS System). U.S. Food and Drug Administration, 2008. accessdata.fda.gov
- 510(k) K083538: NeuroStar TMS Therapy System Model 1.1. U.S. Food and Drug Administration, 2008. accessdata.fda.gov
- 510(k) K160703: NeuroStar TMS Therapy System. U.S. Food and Drug Administration, 2016. accessdata.fda.gov
- 510(k) K212289: NeuroStar Advanced Therapy for OCD. U.S. Food and Drug Administration, 2022. accessdata.fda.gov
- 510(k) K220127: NeuroStar Advanced Therapy System. U.S. Food and Drug Administration, 2022. accessdata.fda.gov
- 510(k) Summary K231926: NeuroStar Advanced Therapy System. U.S. Food and Drug Administration, 2024. accessdata.fda.gov
- 510(k) K122288: BrainsWay Deep TMS System. U.S. Food and Drug Administration, 2013. accessdata.fda.gov
- De Novo Classification Request DEN170078 (BrainsWay Deep TMS for OCD). U.S. Food and Drug Administration, 2018. accessdata.fda.gov
- 510(k) K200957 and K203616: BrainsWay Deep TMS for smoking cessation. U.S. Food and Drug Administration, 2020. accessdata.fda.gov
- 510(k) K210201: BrainsWay Deep TMS System. U.S. Food and Drug Administration, 2021. accessdata.fda.gov
- 510(k) Summary K251449: BrainsWay Deep TMS accelerated protocol. U.S. Food and Drug Administration, 2025. accessdata.fda.gov
- 510(k) Summary K173620: MagVita TMS Therapy System w/Theta Burst Stimulation. U.S. Food and Drug Administration, 2018. accessdata.fda.gov
- 510(k) K251119: MagVenture TMS Therapy System. U.S. Food and Drug Administration, 2025. accessdata.fda.gov
- 510(k) Premarket Notification database records (K231926, K243869, K251125, K243700, K251391, K252358, K260691). U.S. Food and Drug Administration, 2026. accessdata.fda.gov
- 510(k) Summary K220177: Magnus Neuromodulation System with SAINT Technology. U.S. Food and Drug Administration, 2022. accessdata.fda.gov
- 510(k) Summary K260189: MagVenture Accelerated TMS (aTMS) Therapy System. U.S. Food and Drug Administration, 2026. accessdata.fda.gov
- 510(k) K260402: Wave Neuroscience MeRT System. U.S. Food and Drug Administration, 2026. accessdata.fda.gov
- De Novo Classification Request DEN130022 (Cerena Transcranial Magnetic Stimulator). U.S. Food and Drug Administration, 2013. accessdata.fda.gov
- 510(k) K182976: SpringTMS. U.S. Food and Drug Administration, 2019. accessdata.fda.gov
- Clinical TMS Society's Statement on Level of Evidence for Single-Day TMS combined with Medications. Clinical TMS Society, 2025. clinicaltmssociety.org
- Left prefrontal transcranial magnetic stimulation for treatment-resistant depression in adolescents: a double-blind, randomized, sham-controlled trial. Neuropsychopharmacology, 2021. pubmed.ncbi.nlm.nih.gov
- Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clinical Neurophysiology, 2020. pubmed.ncbi.nlm.nih.gov
- Efficacy, Effectiveness, and Safety of Transcranial Magnetic Stimulation for Bipolar Depression: A Systematic Review and Meta-Analysis. Biological Psychiatry Global Open Science, 2026. europepmc.org
- Brief Summary of the Neurological Devices Panel Meeting, March 21, 2019: neuroAD Therapy System. U.S. Food and Drug Administration, 2019. fda.gov
- A systematic review of transcranial magnetic stimulation for generalized anxiety disorder, obsessive-compulsive disorder, and posttraumatic stress disorder. BMC Psychiatry, 2026. europepmc.org
- Consensus Recommendations for the Clinical Application of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Depression. Journal of Clinical Psychiatry, 2018. pmc.ncbi.nlm.nih.gov
- Drugs@FDA: NDA 211243 SPRAVATO. U.S. Food and Drug Administration, 2019. accessdata.fda.gov
- 510(k) Premarket Notification database records, Sep 2025 to Sep 2026 TMS clearances. U.S. Food and Drug Administration, 2026. accessdata.fda.gov
FAQs
Is FDA clearance less safe than FDA approval?
Not in a simple way. The pathway reflects the device class: TMS devices are Class II, so they go through clearance or De Novo rather than the approval route meant for Class III devices. FDA still reviews safety and intended use.
Is TMS FDA-cleared for anxiety?
Only for anxiety symptoms in adults who also have major depression. TMS is not cleared for generalized anxiety disorder on its own.
Is accelerated TMS FDA-cleared?
Some accelerated protocols are: SAINT (2022), BrainsWay AcciTBS (2025) and MagVenture aTMS (2026). Single-day protocols combined with medications are not cleared.
Can a 14-year-old get TMS?
TMS is not cleared for depression under age 15. Any use in younger children would be off-label and needs careful specialist discussion.
Does FDA clearance mean insurance will pay?
No. Insurers set their own criteria, which can be stricter than the label. See does insurance cover TMS.
