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https://www.readbyqxmd.com/read/27930909/fda-regulation-of-neurological-and-physical-medicine-devices-access-to-safe-and-effective-neurotechnologies-for-all-americans
#1
Leigh Anderson, Patrick Antkowiak, Aden Asefa, Amber Ballard, Tushar Bansal, Ayo Bello, Bernard Berne, Kristen Bowsher, Bennett Blumenkopf, Ian Broverman, Mohamad Bydon, Kuo Chao, Peter Como, Karlene Cork, Ann Costello, Kathryn De Laurentis, Angela DeMarco, Heather Dean, John Doucet, Bradley Dworak, Lisa Epperson, Eric Franca, Naz Ghassemian, Chandramallika Ghosh, Anupama Govindarajan, Jay Gupta, Stacie Gutowski, Robert Herrmann, Michael Hoffmann, William Heetderks, Steven Hsu, Daryl Kaufman, Erin Keegan, Gregg Kittlesen, Kevin Khuu, Hyung Lee, Larry Lo, Ian Marcus, Timothy Marjenin, Binoy Mathews, Sanjay Misra, Vivek Pinto, Vesper Ramos, Samuel Raben, Avena Russell, Devjani Saha, Joonil Seog, Christian Shenouda, Myra Smith, Xiaorui Tang, Kelliann Wachrathit, Jaime Waterhouse, Dhanya Williams, Xiaolin Zheng, Carlos Peña
The United States Food and Drug Administration (FDA) ensures that patients in the U.S. have access to safe and effective medical devices. The Division of Neurological and Physical Medicine Devices reviews medical technologies that interface with the nervous system. This article addresses how to navigate the FDA's regulatory landscape to successfully bring medical devices to patients.
December 7, 2016: Neuron
https://www.readbyqxmd.com/read/27917107/the-berlin-brain-computer-interface-progress-beyond-communication-and-control
#2
REVIEW
Benjamin Blankertz, Laura Acqualagna, Sven Dähne, Stefan Haufe, Matthias Schultze-Kraft, Irene Sturm, Marija Ušćumlic, Markus A Wenzel, Gabriel Curio, Klaus-Robert Müller
The combined effect of fundamental results about neurocognitive processes and advancements in decoding mental states from ongoing brain signals has brought forth a whole range of potential neurotechnological applications. In this article, we review our developments in this area and put them into perspective. These examples cover a wide range of maturity levels with respect to their applicability. While we assume we are still a long way away from integrating Brain-Computer Interface (BCI) technology in general interaction with computers, or from implementing neurotechnological measures in safety-critical workplaces, results have already now been obtained involving a BCI as research tool...
2016: Frontiers in Neuroscience
https://www.readbyqxmd.com/read/27852344/neuroscience-fiction-as-eidol%C3%A3-social-reflection-and-neuroethical-obligations-in-depictions-of-neuroscience-in-film
#3
Rachel Wurzman, David Yaden, James Giordano
Neuroscience and neurotechnology are increasingly being employed to assess and alter cognition, emotions, and behaviors, and the knowledge and implications of neuroscience have the potential to radically affect, if not redefine, notions of what constitutes humanity, the human condition, and the "self." Such capability renders neuroscience a compelling theme that is becoming ubiquitous in literary and cinematic fiction. Such neuro-SciFi (or "NeuroS/F") may be seen as eidolá: a created likeness that can either accurately-or superficially, in a limited way-represent that which it depicts...
November 17, 2016: Cambridge Quarterly of Healthcare Ethics: CQ: the International Journal of Healthcare Ethics Committees
https://www.readbyqxmd.com/read/27845682/should-violent-offenders-be-forced-to-undergo-neurotechnological-treatment-a-critical-discussion-of-the-freedom-of-thought-objection
#4
Thomas Søbirk Petersen, Kristian Kragh
In this paper we examine one reason for rejecting the view that violent offenders should be forced to undergo neurotechnological treatments (NTs) involving such therapies as psychoactive medication to curb violent behaviour. The reason is based on the concern that forced treatment violates the offender's right to freedom of thought. We argue that this objection can be challenged. First, we present some specifications of what a right to freedom of thought might mean. We focus on the recently published views of Jared Craig, and Jan Cristopher Bublitz and Reinhard Merkel...
November 14, 2016: Journal of Medical Ethics
https://www.readbyqxmd.com/read/27814514/on-the-necessity-of-ethical-guidelines-for-novel-neurotechnologies
#5
Sara Goering, Rafael Yuste
Because novel neurotechnologies may alter human identity and society in profound ways, we advocate for the early integration of ethics into neurotechnology. We recommend developing and adopting a set of guidelines, like the Belmont Report on human subject research, as a framework for development and use of brain-related technologies.
November 3, 2016: Cell
https://www.readbyqxmd.com/read/27810013/view-from-silicon-valley-maximizing-the-scientific-impact-of-global-brain-initiatives-through-entrepreneurship
#6
Pushkar S Joshi, Kunal K Ghosh
In this era of technology-driven global neuroscience initiatives, the role of the neurotechnology industry remains woefully ambiguous. Here, we explain why industry is essential to the success of these global initiatives, and how it can maximize the scientific impact of these efforts by (1) scaling and ultimately democratizing access to breakthrough neurotechnologies, and (2) commercializing technologies as part of integrated, end-to-end solutions that accelerate neuroscientific discovery.
November 2, 2016: Neuron
https://www.readbyqxmd.com/read/27810009/neurotechnology-and-society-strengthening-responsible-innovation-in-brain-science
#7
Hermann Garden, Diana M Bowman, Sebastian Haesler, David E Winickoff
Technological advances have the potential to dramatically increase our understanding of the human brain, treat and cure injury and disease, and enhance our general well-being. While advances in neuroscience hold great promise, they also raise profound ethical, legal, and social questions. In this vein, the Organization for Economic Co-operation and Development (OECD) convened an international workshop in September 2016 to explore responsible research and innovation in brain science.
November 2, 2016: Neuron
https://www.readbyqxmd.com/read/27809998/brain-minds-a-japanese-national-brain-project-for-marmoset-neuroscience
#8
Hideyuki Okano, Erika Sasaki, Tetsuo Yamamori, Atsushi Iriki, Tomomi Shimogori, Yoko Yamaguchi, Kiyoto Kasai, Atsushi Miyawaki
Brain/MINDS (Brain Mapping by Integrated Neurotechnologies for Disease Studies) is a national brain project started by Japan in 2014. With the goal of developing the common marmoset as a model animal for neuroscience, the project aims to build a multiscale marmoset brain map, develop new technologies for experimentalists, create transgenic lines for brain disease modeling, and integrate translational findings from the clinical biomarker landscape. Brain/MINDS will collaborate with global brain projects to share technologies and resources...
November 2, 2016: Neuron
https://www.readbyqxmd.com/read/27809996/the-brain-initiative-building-strengthening-and-sustaining
#9
Christopher L Martin, Miyoung Chun
Successful federal initiatives share a focus on tangible success stories, constant input and guidance from scientists, participation by a wide range of funders, ongoing interest from policy makers, and a broad and effective communications network. By comparing these elements of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative with other initiatives, we look at what needs to be done to sustain the BRAIN Initiative in the years to come.
November 2, 2016: Neuron
https://www.readbyqxmd.com/read/27762376/neurotechnology-paralysed-man-with-implant-feels-touch
#10
(no author information available yet)
No abstract text is available yet for this article.
October 19, 2016: Nature
https://www.readbyqxmd.com/read/27747793/a-preliminary-study-of-the-effectiveness-of-an-allostatic-closed-loop-acoustic-stimulation-neurotechnology-in-the-treatment-of-athletes-with-persisting-post-concussion-symptoms
#11
Charles H Tegeler, Catherine L Tegeler, Jared F Cook, Sung W Lee, Lee Gerdes, Hossam A Shaltout, Christopher M Miles, Sean L Simpson
BACKGROUND: Effective interventions are needed for individuals with persisting post-concussion symptoms. High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®) is an allostatic, closed-loop, acoustic stimulation neurotechnology, designed to facilitate relaxation and self-optimization of neural oscillations. METHODS: Fifteen athletes (seven females, mean age 18.1 years, SD 2.6) with persisting post-concussion symptoms received 18.7 (SD 6...
December 2016: Sports Medicine—Open
https://www.readbyqxmd.com/read/27727219/recent-patents-in-neurotechnology-and-neuroengineering
#12
(no author information available yet)
No abstract text is available yet for this article.
October 11, 2016: Nature Biotechnology
https://www.readbyqxmd.com/read/27646569/a-four-part-working-bibliography-of-neuroethics-part-3-second-tradition-neuroethics-ethical-issues-in-neuroscience
#13
EDITORIAL
Amanda Martin, Kira Becker, Martina Darragh, James Giordano
BACKGROUND: Neuroethics describes several interdisciplinary topics exploring the application and implications of engaging neuroscience in societal contexts. To explore this topic, we present Part 3 of a four-part bibliography of neuroethics' literature focusing on the "ethics of neuroscience." METHODS: To complete a systematic survey of the neuroethics literature, 19 databases and 4 individual open-access journals were employed. Searches were conducted using the indexing language of the U...
September 19, 2016: Philosophy, Ethics, and Humanities in Medicine: PEHM
https://www.readbyqxmd.com/read/27634728/commentary-the-value-of-patient-benefit-consideration-of-framing-contingencies-to-guide-the-ethical-use-of-dbs-a-case-analysis
#14
James Giordano
Here we have a case in which (1) the outcome(s) for the patient do not comport with the projected-or initially defined-outcomes of the research study, and (2) these outcomes represent cognitive and behavioral effects that are positively interpreted by the patient, but not by the patient's immediate family. The 6Cs approach, which frames the technique or technology-and its effects-within defined considerations of domains and dimensions, can be used as part of a multistep approach to addressing issues arising from the use of neurotechnology...
October 2016: Cambridge Quarterly of Healthcare Ethics: CQ: the International Journal of Healthcare Ethics Committees
https://www.readbyqxmd.com/read/27634722/don-t-ask-a-neuroscientist-about-phases-of-the-moon
#15
Katherine Shats, Timothy Brindley, James Giordano
Ongoing developments in neuroscientific techniques and technologies-such as neuroimaging-offer potential for greater insight into human behavior and have fostered temptation to use these approaches in legal contexts. Neuroscientists are increasingly called on to provide expert testimony, interpret brain images, and thereby inform judges and juries who are tasked with determining the guilt or innocence of an individual. In this essay, we draw attention to the actual capabilities and limitations of currently available assessment neurotechnologies and examine whether neuroscientific evidence presents unique challenges to existing frameworks of evidence law...
October 2016: Cambridge Quarterly of Healthcare Ethics: CQ: the International Journal of Healthcare Ethics Committees
https://www.readbyqxmd.com/read/27634714/the-effects-of-closed-loop-medical-devices-on-the-autonomy-and-accountability-of-persons-and-systems
#16
Philipp Kellmeyer, Thomas Cochrane, Oliver Müller, Christine Mitchell, Tonio Ball, Joseph J Fins, Nikola Biller-Andorno
Closed-loop medical devices such as brain-computer interfaces are an emerging and rapidly advancing neurotechnology. The target patients for brain-computer interfaces (BCIs) are often severely paralyzed, and thus particularly vulnerable in terms of personal autonomy, decisionmaking capacity, and agency. Here we analyze the effects of closed-loop medical devices on the autonomy and accountability of both persons (as patients or research participants) and neurotechnological closed-loop medical systems. We show that although BCIs can strengthen patient autonomy by preserving or restoring communicative abilities and/or motor control, closed-loop devices may also create challenges for moral and legal accountability...
October 2016: Cambridge Quarterly of Healthcare Ethics: CQ: the International Journal of Healthcare Ethics Committees
https://www.readbyqxmd.com/read/27623566/m3ba-a-mobile-modular-multimodal-biosignal-acquisition-architecture-for-miniaturized-eeg-nirs-based-hybrid-bci-and-monitoring
#17
Alexander von Luhmann, Heidrun Wabnitz, Tilmann Sander, Klaus-Robert Muller
OBJECTIVE: For the further development of the fields of telemedicine, neurotechnology and Brain-Computer Interfaces (BCI), advances in hybrid multimodal signal acquisition and processing technology are invaluable. Currently, there are no commonly available hybrid devices combining bio-electrical and bio-optical neurophysiological measurements (here Electroencephalography (EEG) and functional Near Infrared Spectroscopy (fNIRS)). Our objective was the design of such an instrument, and that in a miniaturized, customizable and wireless form...
September 9, 2016: IEEE Transactions on Bio-medical Engineering
https://www.readbyqxmd.com/read/27557104/simulation-neurotechnologies-for-advancing-brain-research-parallelizing-large-networks-in-neuron
#18
William W Lytton, Alexandra H Seidenstein, Salvador Dura-Bernal, Robert A McDougal, Felix Schürmann, Michael L Hines
Large multiscale neuronal network simulations are of increasing value as more big data are gathered about brain wiring and organization under the auspices of a current major research initiative, such as Brain Research through Advancing Innovative Neurotechnologies. The development of these models requires new simulation technologies. We describe here the current use of the NEURON simulator with message passing interface (MPI) for simulation in the domain of moderately large networks on commonly available high-performance computers (HPCs)...
October 2016: Neural Computation
https://www.readbyqxmd.com/read/27509295/autonomous-optimization-of-targeted-stimulation-of-neuronal-networks
#19
Sreedhar S Kumar, Jan Wülfing, Samora Okujeni, Joschka Boedecker, Martin Riedmiller, Ulrich Egert
Driven by clinical needs and progress in neurotechnology, targeted interaction with neuronal networks is of increasing importance. Yet, the dynamics of interaction between intrinsic ongoing activity in neuronal networks and their response to stimulation is unknown. Nonetheless, electrical stimulation of the brain is increasingly explored as a therapeutic strategy and as a means to artificially inject information into neural circuits. Strategies using regular or event-triggered fixed stimuli discount the influence of ongoing neuronal activity on the stimulation outcome and are therefore not optimal to induce specific responses reliably...
August 2016: PLoS Computational Biology
https://www.readbyqxmd.com/read/27489455/neurotechnological-assessment-of-consciousness-disorders-five-ethical-imperatives
#20
Kathinka Evers
Disorders of consciousness (DOCs) cause great human suffering and material costs for society. Understanding of these disorders has advanced remarkably in recent years, but uncertainty remains with respect to the diagnostic criteria and standards of care. One of the most serious problems concerns misdiagnoses, their impact on medical decision-making, and on patients' well-being. Recent studies use neurotechnology to assess residual consciousness in DOC patients that traditional behavioral diagnostic criteria are unable to detect...
June 2016: Dialogues in Clinical Neuroscience
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