As of January 2026, the FDA had authorized under two regulatory pathways the marketing of more than 50 TMS devices for various indications of use within the United States. These pathways are (1) the
premarket notification (PMN), also known as a 510(k) submission, and (2) the
de novo classification request. The FDA
clears medical devices for marketing under a PMN if it finds that the intended use and technological characteristics of a new device are "substantially equivalent" to a legally marketed device (termed a "predicate device"). The FDA also clears medical devices for marketing under a PMN if it finds that (1) a new device has the same intended use as the predicate and has different technological characteristics, (2) the information submitted to the FDA does not raise new types of questions of safety and effectiveness, and (3) the information demonstrates that the new device has a comparable risk-to-benefit profile to a legally marketed device.
Depression In July 2011, in response to a petition by the US company,
Neuronetics, Inc., the FDA classified under its
de novo classification pathway the NeuroStar TMS System as a
Class II (moderate risk) medical device for the treatment of MDD in patients who have failed to receive benefit from one antidepressant trial. In September 2021, in response to a PMN by The Magstim Company Ltd., the FDA cleared the Horizon 3.0 TMS Therapy System for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. In March 2023, in response to a PMN by The Magstim Company Ltd., the FDA cleared the Horizon 3.0 TMS Therapy System for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from MDD and who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. In October 2023, in response to a PMN by The Magstim Company Ltd., the FDA cleared the Horizon 3.0 TMS Therapy System for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from OCD.
Headache In March 2013, in response to a request by the US company eNeura Therapuetics LLC, the FDA classified under its
de novo classification pathway as a Class II medical device the eNeura Therapeutics® CerenaTM Transcranial Magnetic Stimulator for the acute treatment of pain associated with migraine headache with aura.
Obsessive–compulsive disorder (OCD) In September 2017, the FDA classified the Brainsway Deep Transcranial Magnetic Stimulation System as an adjunct for the treatment of adult patients suffering from OCD as a Class II medical device under its
de novo classification pathway in response to a request from Brainsway Ltd. In August 2018, the FDA permitted the marketing of the device for the treatment of OCD in response to a subsequent
de novo classification request from the company. In August 2020, the FDA cleared the MagVenture TMS Therapy system for the treatment of OCD in response to a PMN by the
Danish company Tonica Elektronik A/S. In May 2022, the FDA cleared the NeuroStar Advanced Therapy for the adjunctive treatment of OCD in response to a PMN by Neuronetics, Inc. In October 2023, in response to a PMN by The Magstim Company Ltd., the FDA cleared the Horizon 3.0 TMS Therapy System for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from OCD.
Psychiatric disorders and conditions In August 2018, in response to a request by Brainsway Ltd., the FDA classified under its
de novo classification pathway the generic type of device transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions as a Class II medical device that is identified as a prescription, non-implantable device that uses brief duration, rapidly alternating, or pulsed, magnetic fields to induce neural activity in the cerebral cortex.
Smoking cessation In August 2020, the FDA cleared the Brainsway Deep TMS System for use as an aid in short term smoking cessation in adults in response to a PMN by Brainsway Ltd.
Criticism of FDA regulatory procedures for medical devices In 1993, the US House of Representatives' Subcommittee on Oversight and Investigations of its
Committee on Energy and Commerce issued a report entitled "Less Than The Sum Of Its Parts". The report identified a number of continued organizational and structural weaknesses that had made the
FDA Center for Devices and Radiological Health unable to either adequately protect the public from unsafe devices or to approve useful and safe devices in a reasonable period of time. A 2010 review of the FDA's regulatory procedures subsequently contended that, among other things, the agency's reviews of medical devices had a lower approval standard than their drug counterparts, excessively relied upon a fast-track process, and failed to conduct Congressionally-mandated device classifications.
Other areas In the
European Economic Area, various versions of deep TMS H-coils have
CE marking for
Alzheimer's disease, chronic pain, PTSD,
schizophrenia (negative symptoms) and to aid smoking cessation. One review found tentative benefit for cognitive enhancement in healthy people.
Coverage by health services and insurers United Kingdom The United Kingdom's NICE issues guidance to the
National Health Service (NHS) in England, Wales, Scotland, and Northern Ireland. NICE guidance does not address whether the NHS should fund a procedure. Local NHS bodies (
primary care trusts and
hospital trusts) make decisions about funding after considering the clinical effectiveness of the procedure and whether the procedure represents value for money for the NHS. NICE evaluated TMS for severe depression in 2007, finding that TMS was safe, but with insufficient evidence for its efficacy. Guidance was updated and replaced in 2015, concluding that evidence for short‑term efficacy of rTMS for depression was adequate, although the clinical response is variable, and ruling that rTMS for depression may be used with arrangements for clinical governance and audit. In January 2014, NICE reported the results of an evaluation of TMS for treating and preventing migraine (IPG 477). NICE found that short-term TMS is safe but there is insufficient evidence to evaluate safety for long-term and frequent uses. It found that evidence on the efficacy of TMS for the treatment of migraine is limited in quantity, that evidence for the prevention of migraine is limited in both quality and quantity. , use of rTMS in the UK was reported to have remained limited due to the cost of equipment and establishing treatment centres. Camilla Nord, head of the Mental Health Neuroscience Lab at the
University of Cambridge said, "The NHS has unfortunately been far behind the US and Canada on rTMS, which is at least as effective as antidepressants, if not more".
United States ;Commercial health insurance In 2013, several commercial health insurance plans in the United States, including
Anthem,
Health Net,
Kaiser Permanente, and
Blue Cross Blue Shield of
Nebraska and of
Rhode Island, covered TMS for the treatment of depression for the first time. In contrast,
UnitedHealthcare issued a medical policy for TMS in 2013 that stated there is insufficient evidence that the procedure is beneficial for health outcomes in patients with depression. UnitedHealthcare noted that methodological concerns raised about the scientific evidence studying TMS for depression include small sample size, lack of a validated sham comparison in randomized controlled studies, and variable uses of outcome measures. Other commercial insurance plans whose 2013 medical coverage policies stated that the role of TMS in the treatment of depression and other disorders had not been clearly established or remained investigational included
Aetna,
Cigna and
Regence. ;Medicare Policies for Medicare coverage vary among local jurisdictions within the Medicare system, and Medicare coverage for TMS has varied among jurisdictions and with time. For example: • In early 2012 in
New England, Medicare covered TMS for the first time in the United States. However, that jurisdiction later decided to end coverage after October, 2013. • In August 2012, the jurisdiction covering Arkansas, Louisiana, Mississippi, Colorado, Texas, Oklahoma, and New Mexico determined that there was insufficient evidence to cover the treatment, but the same jurisdiction subsequently determined that Medicare would cover TMS for the treatment of depression after December 2013. == Limitations ==