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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: heetderks w. 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. Among authors: heetderks w. 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: heetderks w. Neuromodulation. 2020 Jan;23(1):3-9. doi: 10.1111/ner.13085. Neuromodulation. 2020. PMID: 31965667 Review.
Patient-Centered Identification of Meaningful Regulatory Endpoints for Medical Devices to Treat Parkinson's Disease.
Benz HL, Caldwell B, Ruiz JP, Saha A, Ho M, Christopher S, Bardot D, Sheehan M, Donnelly A, McLaughlin L, Mange B, Hauber AB, Gwinn K, Heetderks WJ, Sheldon M. Benz HL, et al. MDM Policy Pract. 2021 Jul 2;6(1):23814683211021380. doi: 10.1177/23814683211021380. eCollection 2021 Jan-Jun. MDM Policy Pract. 2021. PMID: 34277950 Free PMC article.
Concordance of SARS-CoV-2 Results in Self-collected Nasal Swabs vs Swabs Collected by Health Care Workers in Children and Adolescents.
Waggoner JJ, Vos MB, Tyburski EA, Nguyen PV, Ingersoll JM, Miller C, Sullivan J, Griffiths M, Stone C, Benoit M, Benedit L, Seitter B, Jerris R, Levy JM, Kraft CS, Farmer S, Peagler A, Wood A, Westbrook AL, Morris CR, Sathian UN, Heetderks W, Li L, Roth K, Barcus M, Stenzel T, Martin GS, Lam WA. Waggoner JJ, et al. Among authors: heetderks w. JAMA. 2022 Sep 13;328(10):935-940. doi: 10.1001/jama.2022.14877. JAMA. 2022. PMID: 36018570 Free PMC article.
Longitudinal Assessment of Diagnostic Test Performance Over the Course of Acute SARS-CoV-2 Infection.
Smith RL, Gibson LL, Martinez PP, Ke R, Mirza A, Conte M, Gallagher N, Conte A, Wang L, Fredrickson R, Edmonson DC, Baughman ME, Chiu KK, Choi H, Jensen TW, Scardina KR, Bradley S, Gloss SL, Reinhart C, Yedetore J, Owens AN, Broach J, Barton B, Lazar P, Henness D, Young T, Dunnett A, Robinson ML, Mostafa HH, Pekosz A, Manabe YC, Heetderks WJ, McManus DD, Brooke CB. Smith RL, et al. Among authors: heetderks wj. J Infect Dis. 2021 Sep 17;224(6):976-982. doi: 10.1093/infdis/jiab337. J Infect Dis. 2021. PMID: 34191025 Free PMC article.
43 results