The United States Food and Drug Administration (FDA) ensures that patients in the United States 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, including many neuromodulation devices. This article focuses on neuromodulation devices and addresses how to navigate the FDA's regulatory landscape to successfully bring devices to patients.
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http://dx.doi.org/10.1111/ner.13085 | DOI Listing |
BMJ
December 2024
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA 02120, USA.
Objective: To compare the effectiveness and safety of budesonide-glycopyrrolate-formoterol, a twice daily metered dose inhaler, and fluticasone-umeclidinium-vilanterol, a once daily dry powder inhaler, in patients with chronic obstructive pulmonary disease (COPD) treated in routine clinical practice.
Design: New user cohort study.
Setting: Longitudinal commercial US claims data.
Sensors (Basel)
December 2024
Shandong Provincial Key Laboratory of Monocrystalline Silicon Semiconductor Materials and Technology, Shandong Provincial Engineering Research Center of Organic Functional Materials and Green Low-Carbon Technology, Shandong Universities Engineering Research Center of Integrated Circuits Functional Materials and Expanded Applications, College of Chemistry and Chemical Engineering, Dezhou University, Dezhou 253023, China.
In this paper, a novel molecularly imprinted polymer membrane modified glassy carbon electrode for electrochemical sensors (MIP-OH-MWCNTs-GCE) for epinephrine (EP) was successfully prepared by a gel-sol method using an optimized functional monomer oligosilsesquioxane-AlO sol-ITO composite sol (ITO-POSS-AlO). Hydroxylated multi-walled carbon nanotubes (OH-MWCNTs) were introduced during the modification of the electrodes, and the electrochemical behavior of EP on the molecularly imprinted electrochemical sensors was probed by the differential pulse velocity (DPV) method. The experimental conditions were optimized.
View Article and Find Full Text PDFSensors (Basel)
December 2024
Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing 100032, China.
Investigating the physiological mechanisms in the motor cortex during rehabilitation exercises is crucial for assessing stroke patients' progress. This study developed a single-channel Jansen neural mass model to explore the relationship between model parameters and motor cortex mechanisms. Firstly, EEG signals were recorded from 11 healthy participants under 20%, 40%, and 60% maximum voluntary contraction, and alpha rhythm power spectral density characteristics were extracted using the Welch power spectrum method.
View Article and Find Full Text PDFBiomed Chromatogr
February 2025
Department of Chemistry, GITAM School of Science, GITAM Deemed to Be University, Hyderabad, India.
A simple LC method has been developed and validated for estimating budesonide (epimer B + A) and formoterol fumarate dihydrate in dry powder inhalation. The development results of this study make it very significant. The degradation and process impurities in EP and ChP were identified in addition to budesonide and formoterol fumarate.
View Article and Find Full Text PDFAnal Chim Acta
January 2025
Center for Quantum Sciences and School of Physics, Northeast Normal University, Changchun, 130117, China.
Background: Adrenaline and glucose are essential biomarkers in human body for maintaining metabolic balance. Abnormal levels of adrenaline and glucose are associated with various diseases. Therefore, it is important to design portable, on-site devices for rapid adrenaline and glucose analysis to safeguard health.
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