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Brain-computer interface devices for patients with paralysis and amputation: a meeting report.
Bowsher K, Civillico EF, Coburn J, Collinger J, Contreras-Vidal JL, Denison T, Donoghue J, French J, Getzoff N, Hochberg LR, Hoffmann M, Judy J, Kleitman N, Knaack G, Krauthamer V, Ludwig K, Moynahan M, Pancrazio JJ, Peckham PH, Pena C, Pinto V, Ryan T, Saha D, Scharen H, Shermer S, Skodacek K, Takmakov P, Tyler D, Vasudevan S, Wachrathit K, Weber D, Welle CG, Ye M. Bowsher K, et al. Among authors: pena c. J Neural Eng. 2016 Apr;13(2):023001. doi: 10.1088/1741-2560/13/2/023001. Epub 2016 Feb 29. J Neural Eng. 2016. PMID: 26924826
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: pena c. Neuron. 2016 Dec 7;92(5):943-948. doi: 10.1016/j.neuron.2016.10.036. Neuron. 2016. PMID: 27930909 Free article.
Update to Food and Drug Administration Regulation of Stroke Neurological Devices.
Peña C, Anderson L, Brooks C, Bydon M, Fusco M, Heetderks W, Herrmann R, Hoffmann M, Loftus C, Raben S, Seog J, Noonan P, Smith M, Williams D, Zheng X. Peña C, et al. Stroke. 2019 Feb;50(2):524-528. doi: 10.1161/STROKEAHA.118.021078. Stroke. 2019. PMID: 30661499 Free article. Review. No abstract available.
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. Among authors: pena c. Neuromodulation. 2020 Jan;23(1):3-9. doi: 10.1111/ner.13085. Neuromodulation. 2020. PMID: 31965667 Review.
Continuing to strengthen FDA's science approach to emerging technologies.
Anatol R, Bauer S, Epstein S, Filice R, Lauritsen K, Lee MH, Mansfield E, McMurry-Heath M, Milone J, Peña C, Pollack S, Zineh I. Anatol R, et al. Among authors: pena c. Nanomedicine. 2013 Jul;9(5):594-9. doi: 10.1016/j.nano.2013.04.005. Epub 2013 May 18. Nanomedicine. 2013. PMID: 23692697
1,344 results