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Definition of Implanted Neurological Device Abandonment: A Systematic Review and Consensus Statement.
JAMA Netw Open. 2024 Apr 1;7(4):e248654. doi: 10.1001/jamanetworkopen.2024.8654.
JAMA Netw Open. 2024.
PMID: 38687486
Free article.
Regulatory Framework for Implantable Neurostimulation Devices: Comparison of Systems in the US and European Union.
Amon A, Marjenin T, Duarte RV, Gilligan C, Thomson SJ, Eldabe S, Alesch F.
Amon A, et al. Among authors: marjenin t.
Neuromodulation. 2024 Apr;27(3):447-454. doi: 10.1016/j.neurom.2023.04.472. Epub 2023 Jun 10.
Neuromodulation. 2024.
PMID: 37306642
Review.
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Limited output transcranial electrical stimulation 2023 (LOTES-2023): Updates on engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk.
Bikson M, Ganho-Ávila A, Datta A, Gillick B, Joensson MG, Kim S, Kim J, Kirton A, Lee K, Marjenin T, Onarheim B, Rehn EM, Sack AT, Unal G.
Bikson M, et al. Among authors: marjenin t.
Brain Stimul. 2023 May-Jun;16(3):840-853. doi: 10.1016/j.brs.2023.05.008. Epub 2023 May 16.
Brain Stimul. 2023.
PMID: 37201865
Free PMC article.
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FDA Perspectives on the Regulation of Neuromodulation Devices.
Marjenin T, Scott P, Bajaj A, Bansal T, Berne B, Bowsher K, Costello A, Doucet J, Franca E, Ghosh C, Govindarajan A, Gutowski S, Gwinn K, Hinckley S, Keegan E, Lee H, Mathews B, Misra S, Patel S, Tang X, Heetderks W, Hoffmann M, Pena C.
Marjenin T, et al.
Neuromodulation. 2020 Jan;23(1):3-9. doi: 10.1111/ner.13085.
Neuromodulation. 2020.
PMID: 31965667
Review.
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FDA Regulation of Neurological and Physical Medicine Devices: Access to Safe and Effective Neurotechnologies for All Americans.
Anderson L, Antkowiak P, Asefa A, Ballard A, Bansal T, Bello A, Berne B, Bowsher K, Blumenkopf B, Broverman I, Bydon M, Chao K, Como P, Cork K, Costello A, De Laurentis K, DeMarco A, Dean H, Doucet J, Dworak B, Epperson L, Franca E, Ghassemian N, Ghosh C, Govindarajan A, Gupta J, Gutowski S, Herrmann R, Hoffmann M, Heetderks W, Hsu S, Kaufman D, Keegan E, Kittlesen G, Khuu K, Lee H, Lo L, Marcus I, Marjenin T, Mathews B, Misra S, Pinto V, Ramos V, Raben S, Russell A, Saha D, Seog J, Shenouda C, Smith M, Tang X, Wachrathit K, Waterhouse J, Williams D, Zheng X, Peña C.
Anderson L, et al. Among authors: marjenin t.
Neuron. 2016 Dec 7;92(5):943-948. doi: 10.1016/j.neuron.2016.10.036.
Neuron. 2016.
PMID: 27930909
Free article.
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