Brain Stimulation 15 (2022) 73e75

Contents lists available at ScienceDirect

Brain Stimulation
journal homepage: http://www.journals.elsevier.com/brain-stimulation

A visual and narrative timeline of US FDA milestones for Transcranial

Magnetic Stimulation (TMS) devices

Dear Editor, from prior antidepressant medication in the current episode. Also
cleared in 2017 by FDA regulation was the eNeura Spring TMS
It has been over a decade since the initial US Food and Drug (K162797) for both acute and prophylactic treatment of migraine
Administration (FDA) approval of Transcranial Magnetic Stimula- headache.
tion (TMS). The technology was first approved for treating Major New pulse parameters, such as theta burst stimulation have also
Depressive Disorder (MDD) in adults who have not responded demonstrated utility in improving TMS therapeutic effects. The first
satisfactorily to prior antidepressant medications in 2008 using device receiving clearance for the intermittent Theta Burst Stimula-
the Neuronetics Neurostar System (DEN070003). Since then, tion (iTBS) protocol was the Tonika Elektronik (Magventure) Mag
refinement and optimization of TMS has paved the way to new Vita TMS Therapy System with Theta Burst Stimulation (K173620)
and emerging technology that improves and broadens the clinical in 2018 for the treatment of MDD in adults previously failing to
utility of TMS e such as pulse train protocols (e.g., iTBS and 18/20 improve symptoms with antidepressant medication. Mag & More
Hz stimulation), neuronavigational systems, and electromagnetic also received clearance for the Apollo TMS System (K180313) for
coil technology. Alongside ongoing clinical trials, the approval of the same indication that year.
TMS therapies by the FDA has underpinned clinical adoption in The following year, two more devices received clearance for the
the US. Here we summarize FDA regulatory milestones for TMS iTBS protocol. Magstim's Horizon TMS Therapy System with Navi-
and provide a visual timeline of these approvals in Fig. 1. gation (K183376) for MDD added StimGuide for coil positioning us-
Following the 2008 FDA approval of TMS for depression, the ing scalp landmarks, in addition to the iTBS protocol. Nexstim's NBT
Nexstim eXimia NBS System was the first device FDA-cleared for System 2 (K182700) for MDD also added iTBS treatment capabil-
cortical mapping (K091457) under the 510(k) pathway in 2009. ities. Also in 2019, the eNeura Spring TMS (K182976) expanded
Following this clearance, the Nexstim NBS System 4 was subse- its indications for acute and prophylactic treatment of migraine
quently FDA-cleared for cortical mapping in 2012 with the addition headaches in adolescents and adults. The same year, Axilum Ro-
of NEXSPEECH for localization and assessment of cortical areas of botics' TMS-Cobot TS MV (K182768) indicated for spatial posi-
speech for pre-procedural planning (K112881). tioning and orientation of the treatment coil of the MagVita TMS
The BrainsWay Deep TMS was cleared in 2013 for the treatment System received clearance. The de novo request by Neuronix for
of depressive episodes in patients suffering from MDD who have the neuroAD Therapy System (DEN160053) for the treatment of
failed to achieve sufficient improvement from prior antidepressant Alzheimer's Disease was denied in 2019.
medication (K122288). This same year the eNeura Cerena System Neuronetics added the iTBS protocol with Neurostar Advanced
become the first cleared for acute treatment of pain associated Therapy with NeuroBurst (K201158) for the treatment of MDD in
with migraine with aura (K130556), using a handheld and deliv- 2020. Tonica Elektronik also received clearance for the MagVenture
ered with minimal training. The following year, in 2014, eNeura TMS Therapy (K193006) for adjunctive treatment of OCD the same
was cleared for a portable device for treatment of migraine head- year. The Soterix Medical Neural Navigator (K191422) received
ache with aura with Spring TMS (K140094). clearance in 2020 as a neuronavigation system guided by MRI-
Moving into 2015, the field saw an expansion of two additional based measurements for accurate positioning of the treatment
TMS devices which received clearance for the treatment of MDD in coils. BrainsWay's Deep TMS System (K200957) became the first
patients who have failed to receive improvements from prior anti- to be cleared as an aid in short-term smoking cessation for adults
depressant medication: Tonica Elektronik (Magventure)'s MagVita in 2020. Finally, the clearance of BrainsWay's Deep TMS System
TMS (K150641) and Magstim's Rapid2 System (K143531). Tele- expanded the technology's indications to include the treatment of
EMG's Neurosoft TMS (K160309) received clearance for the same depressive episodes and decreasing anxiety symptoms for those
indication a year later. who may exhibit comorbid anxiety, previously failing to achieve
Aside from MDD, the next psychiatric condition that was FDA- satisfactory improvements with antidepressant medication for
approved was obsessive compulsive disorder (OCD). With the de MDD (K210201).
novo pathway, BrainsWay's Deep TMS System became the first to The TMS field has grown substantially over the past two de-
receive FDA approval as an adjunct for the treatment of OCD in cades, moving from promising research findings to numerous
adults in 2017 (DEN170078). The Nexstim Navigated Brain Therapy FDA-approved medical devices with broad ranging treatment util-
System 2 (K171902) was cleared in the same year for treatment of ity in neurological and psychiatric disorders. Several new indica-
MDD in those who have failed to achieve satisfactory improvement tions such as OCD, anxiety comorbid with MDD, and smoking

https://doi.org/10.1016/j.brs.2021.11.010
1935-861X/© 2021 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
S.L. Cohen, M. Bikson, B.W. Badran et al. Brain Stimulation 15 (2022) 73e75

Fig. 1. Timeline of US FDA milestones for Transcranial Magnetic Stimulation (TMS) devices.

have emerged. Based on this record and ongoing efforts to enhance Samantha L. Cohen, Marom Bikson, Bashar W. Badran, Mark S.
TMS technology and explore new treatment indications, further George.
meaningful advances are expected.

74
S.L. Cohen, M. Bikson, B.W. Badran et al. Brain Stimulation 15 (2022) 73e75

Declarations of competing interest Samantha L. Cohen*

Department of Biomedical Engineering, The City College of New York,
SLC: none. CUNY, New York, NY, 10031, USA
The City University of New York holds patents on brain stimula-
Department of Biomedical Engineering, University of Southern
tion with MB as inventor. MB has equity in Soterix Medical Inc. MB
California, Los Angeles, CA, 90007, USA
consults, received grants, assigned inventions, and/or serves on the
SAB of Boston Scientific, GlaxoSmithKline, Biovisics, Mecta, Lume- Marom Bikson
nis, Halo Neuroscience, Google-X, i-Lumen, Humm, Allergan Department of Biomedical Engineering, The City College of New York,
(Abbvie). CUNY, New York, NY, 10031, USA
MB is supported by grants from Harold Shames and the National
Bashar W. Badran
Institutes of Health: NIH-NIDA UG3DA048502, NIH-NIGMS
Department of Psychiatry, Medical University of South Carolina,
T34GM137858, NIH-NINDS 1R01NS112996, NIH-NINDS
Charleston, SC, 29425, USA
1R01NS101362, NIH-NIMH 1R01MH111896, and NIH-NINDS
1R01NS095123. Mark S. George
BWB is a named inventor on brain stimulation patents assigned Department of Psychiatry, Medical University of South Carolina,
to the Medical University of South Carolina, owns stock in Bodhi Charleston, SC, 29425, USA
NeuroTech, Inc., and serves as a consultant to companies that
Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA
commercialize brain stimulation technology.
BB is funded by the NIH under grants 5P20GM109040-08, *
1R43DA050360-01, 5P2CHD086844-05, and 1P50DA046373-01A1. Corresponding author.
MSG served as a Journal Editor for Elsevier Press and as a Data E-mail address: [email protected] (S.L. Cohen).
Safety Monitoring Board member for Microtransponder Neuro-
netics, and is a member of the BrainsWay SAB. 26 September 2021
Available online 11 November 2021

75