FDA Clearance History for TMS Devices: A Complete Timeline

How TMS became a mainstream treatment

TMS didn’t arrive in clinical practice overnight. The path from lab curiosity to FDA-cleared treatment spanned decades of research, regulatory back-and-forth, and iterative device development. Each clearance expanded the conditions TMS can treat and the technologies available to clinicians.

Why does this timeline matter to you? FDA clearance determines insurance coverage, shapes clinical guidelines, and tells you which indications have the strongest evidence behind them. Here’s every major milestone.

2008: The breakthrough — NeuroStar for major depressive disorder

Device: Neuronetics NeuroStar TMS Therapy System Indication: Treatment-resistant major depressive disorder (MDD) Clearance type: De novo 510(k)

October 8, 2008. The FDA cleared the first TMS device for clinical use in the United States. This was the one that started everything.

The NeuroStar system, manufactured by Neuronetics, got the green light for treating MDD in adults who had failed at least one adequate antidepressant trial.

The pivotal trial (O’Reardon et al., Biological Psychiatry, 2007;62(11):1208-1216) enrolled 301 medication-free patients across 23 sites — 155 randomized to active TMS and 146 to sham stimulation over the left dorsolateral prefrontal cortex (DLPFC) at 10 Hz, 120% motor threshold, 3,000 pulses per session, for 4-6 weeks. Active TMS was significantly superior to sham on the MADRS, HAMD17, and HAMD24 at weeks 4 and 6. Response rates were approximately twofold higher with active TMS, and the dropout rate for adverse events was just 4.5%.

Those numbers look modest by today’s standards. They were enough to clear the regulatory bar — and here’s the thing: real-world data later showed much higher response rates (58-83%) when TMS was part of actual clinical care rather than the restrictive conditions of a regulatory trial. The largest outcomes registry (Sackeim et al., 2020; 5,010 patients across 103 sites) confirmed this pattern. In the real world, you keep your medications. You get longer treatment courses. Your clinician optimizes for outcomes, not controlled variables.

The NeuroStar clearance used a figure-8 coil delivering repetitive pulses at 10 Hz to the left DLPFC. That protocol became the standard for the next decade.

2013: Deep TMS enters the market — BrainsWay for MDD

Device: BrainsWay Deep TMS System (H1 coil) Indication: Treatment-resistant major depressive disorder Clearance type: De novo 510(k)

January 2013. BrainsWay brought a fundamentally different approach to the table. Instead of the figure-8 coil, BrainsWay used a proprietary H-coil helmet that generates magnetic fields reaching deeper brain structures — roughly 4-6 cm below the skull surface compared to 1.5-2 cm for conventional coils.

The pivotal trial (Levkovitz et al., World Psychiatry, 2015;14(1):64-73) was an international, double-blind, multicenter RCT that randomized 212 MDD patients to active deep TMS or sham. Response rates: 38.4% active versus 21.4% sham. Remission rates: 32.6% versus 14.6%. Benefits were sustained through 16 weeks of follow-up. Notably stronger effect sizes than the original NeuroStar trial, though direct comparisons between different trials are always imprecise.

What this really meant: competition and technological diversity in the TMS market. Clinicians had a choice. If you didn’t respond to one approach, there was an alternative to try.

2018: Beyond depression — BrainsWay H7 coil for OCD

Device: BrainsWay Deep TMS System (H7 coil) Indication: Obsessive-compulsive disorder (OCD) Clearance type: De novo 510(k)

August 2018. A landmark moment. The first TMS clearance for anything other than depression. This validated TMS as a platform technology — not a one-trick device, but a tool that works for multiple psychiatric conditions.

The H7 coil targets the anterior cingulate cortex (ACC) and medial prefrontal cortex — regions at the heart of the cortico-striato-thalamo-cortical (CSTC) circuit that drives OCD. Different coil geometry than the H1 depression coil, because the target structures are deeper and more medial.

The pivotal trial (Carmi et al., American Journal of Psychiatry, 2019;176(11):931-938) enrolled 99 OCD patients and used a unique provocation-augmented protocol. Before each TMS session, you’d be briefly exposed to personalized OCD triggers to activate the relevant circuits, then immediately received 20 Hz deep TMS daily for six weeks. In the FDA-approved analysis set of 94 patients, Y-BOCS scores dropped by 6.0 points in the active group versus 3.3 points in the sham group (p=0.01, effect size d=0.69). Full response rates (30% or greater reduction in Y-BOCS scores): 38.1% active versus 11.1% sham (p=0.003). Partial response rates (20% or greater reduction): 54.8% active versus 26.7% sham (p=0.008). Benefits were maintained at one-month follow-up (effect size d=0.62). Clinically meaningful. Statistically significant.

This opened the door for TMS treatment of conditions beyond depression. Real hope for the estimated 2-3% of the population living with OCD who don’t get enough relief from SSRIs and cognitive-behavioral therapy.

2020: Addiction treatment — BrainsWay for smoking cessation

Device: BrainsWay Deep TMS System (H4 coil) Indication: Short-term smoking cessation Clearance type: De novo 510(k)

August 2020. TMS became the first non-pharmacological brain stimulation treatment cleared for any addictive behavior. A quiet milestone with loud implications.

The H4 coil targets the bilateral insula and prefrontal cortex — brain regions involved in craving, body awareness, and decision-making. The insula has emerged as a key hub for addiction. Lesion studies show that insular damage can lead to abrupt smoking cessation without withdrawal symptoms. That’s a striking finding.

The pivotal trial (Zangen et al., Biological Psychiatry, 2021;89(3):260-268) randomized 262 chronic smokers (averaging 26+ years of smoking with multiple failed quit attempts) to active deep TMS or sham over three weeks. Treatment was delivered after a brief smoking provocation to induce cravings. Among participants who completed treatment, the continuous quit rate (four consecutive weeks of abstinence) was 28.0% in the active group compared to 11.7% in the sham group — roughly 2.4 times more likely to achieve sustained abstinence.

This mattered beyond smoking. It proved that TMS could shift addiction-related neural circuits, fueling ongoing research into TMS for alcohol dependence, opioid use disorder, and other substance use conditions.

2024: Migraine relief — single-pulse TMS

Device: eNeura SpringTMS (sTMS mini) Indication: Acute and preventive treatment of migraine with aura Clearance type: 510(k)

This was a different branch of TMS technology entirely. Unlike repetitive TMS for psychiatric conditions, single-pulse TMS (sTMS) delivers individual magnetic pulses to the occipital cortex at the back of the head. The target: cortical spreading depression, the wave of neural activity believed to underlie migraine aura.

The eNeura device is portable and designed for home use. That’s a first. You place it against the back of your head and deliver two to four pulses when you feel an aura coming on (acute treatment) or on a daily schedule (preventive treatment). No clinic visit needed.

Clinical trial data: meaningful pain relief within two hours for 39% of migraine-with-aura attacks versus 22% for sham. Preventive use reduced headache days per month by about 2.75 days compared to baseline.

The migraine clearance expanded TMS beyond psychiatry entirely. It showed the technology’s range across neurological conditions and opened a path for future neurological applications.

What comes next

Several indications are in late-stage clinical trials. New clearances could arrive within the next few years:

Generalized anxiety disorder — Multiple device manufacturers are running pivotal trials. PTSD is also under active investigation, though the heterogeneity of the condition makes trial design trickier.

Adolescent depression — TMS is currently cleared for adults only. Trials in patients ages 12-17 are underway at several major research institutions. Clearance could dramatically expand access.

Bipolar depression — Modified protocols designed to minimize mania risk are showing promise in Phase II trials.

Substance use disorders beyond smoking — Alcohol use disorder and opioid use disorder trials are progressing, building on the biological rationale from the smoking cessation clearance.

Why FDA clearance matters for you

FDA clearance is the line that triggers insurance coverage. Without it, TMS for a given condition is considered experimental — and almost never covered. Each clearance listed above directly translated into thousands of people gaining access to treatment they couldn’t previously afford.

The history of TMS technology and its regulatory milestones reflect a steady expansion: more conditions treated, more devices available, more people who can benefit. For the latest on where TMS is covered and how to find a provider, browse our state-by-state directory or explore our treatment guides for evidence on specific conditions.