Results 111 to 120 of about 333,056 (304)

Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table.

The European Union (EU) Medical Device Regulation increased regulatory scrutiny to improve the safety and performance of new medical devices. An equally important goal is providing timely access to innovative devices to benefit patient care. The European
Fraser, A.G., Franke, J., Parma, R., Myers, P.O., Weidinger, F., Kurucova, J., Crotti, L., Szymanski, P., Krucoff, M., Byrne, R., O'Connor, D.B., Vincent, A., Stefanini, G., Gilard, M., Lüscher, T.F., Drossart, I., Samset, E., Windecker, S., von Bardeleben, R.S., Abid, L., Kirtane, A.J., Cossellu, M.G., Rappagliosi, A., Piscoi, P., McGauran, G., Rao, A., Brennan, J.   +26 more
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APPROVAL PROCESS AND REGISTRATION PROCESS OF MEDICAL DEVICES IN US, CANADA AND INDIA

, 2019
A medical device is any device intended to be used for medical purpose. Thus what differentiates a medical device from an everyday device is its intended use.
N.Swetha*,D.Nagarjuna Reddy, M.V.Nagabhushanam, B.Brahmaiah, G.Ramakrishna
core   +1 more source

App Neutrality: Apple’s App Store and Freedom of Expression Online

International Journal of Communication, 2013
Apple’s wireless devices have become a critical entry point into the Internet. But unlike the broader Internet, which can be construed as a relatively open communications network, the iOS app store is arguably a closed technological ecosystem. Developers
Luis E. Hestres
doaj  

Added Prognostic Value of EEG Reactivity in Comatose Patients Following Cardiac Arrest

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Objectives To evaluate the added prognostic value of EEG reactivity for favorable outcome compared with background analysis during and after targeted temperature management (TTM). Methods Prospective observational cohort study of comatose post–cardiac arrest patients admitted to a single academic center between 2017 and 2022, all undergoing ...
Sarah Caroyer, Marie Obrecht, Charlotte de Maeseneire, Charlotte Damien, Chantal Depondt, Lorenzo Ferlini, Estelle Rikir, Filippo Annoni, Fabio Silvio Taccone, Nicolas Mavroudakis, Benjamin Legros, Nicolas Gaspard   +11 more
wiley   +1 more source

Comprehensive Assessment of Arterial, Tissue, and Venous Collaterals for Evaluating the Infarct Growth Rate: The Multimodal Collateral Score

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Background Collaterals are crucial factors that influence the infarct growth rate (IGR). We aimed to determine whether a comprehensive multimodal collateral score (MCS), incorporating collateral assessment at the arterial, tissue, and venous levels, is associated with functional independence and provides incremental prognostic value over ...
Giorgio Busto, Umberto Pensato, Ilaria Casetta, Giorgio U. Marcello, Angelo Barra, Anna Poggesi, Edoardo Carlesi, Sara Mancini, Andrea Ginestroni, Vittorio Miele, Alessandro Padovani, Andrea Morotti, Enrico Fainardi   +12 more
wiley   +1 more source

Global Regulatory Challenges for Medical Devices: Impact on Innovation and Market Access

Applied Sciences
Medical devices play a crucial role in human health. These are instruments, machines or even software programs used to diagnose, treat, monitor or prevent health conditions.
Carolina Amaral, Maria Paiva, Ana Rita Rodrigues, Francisco Veiga, Victoria Bell   +4 more
doaj   +1 more source

Problematic Internet Use in Frontotemporal Dementia: A Case Series

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT The present study investigated problematic internet use (PIU) among 61 patients with frontotemporal dementia (FTD) compared to a cohort of 354 patients with mild cognitive impairment (MCI) and Alzheimer's dementia. PIU was identified in 22.9% of FTD patients compared to only 0.8% of AD patients (p < 0.001). Behaviors included compulsive social
Daniele Urso, Giuseppe Volpe, Agnese Valguarnera, Davide Vilella, Alessandra Vitulli, Valentina Gnoni, Alessia Giugno, Eleonora Rollo, Mark D. Griffiths, Giancarlo Logroscino   +9 more
wiley   +1 more source

Evaluation of Digital Technologies for Home‐Based Assessment in People With Amyotrophic Lateral Sclerosis

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Objective Digital technologies hold promise for transforming healthcare by enhancing personalized treatments and offer valuable opportunities to improve patient care. Here, we evaluated several novel, self‐administered, home‐based, digital endpoints for their association with corresponding conventional standard clinical measures (primary) in ...
Arne Mueller, Vanessa Vallejo, Mónica Povedano Panadés, Orla Hardiman, Véronique Danel‐Brunaud, Senda Ajroud‐Driss, Philippe Couratier, Jeremy Shefner, Anna Gokey, Mike DiCesare, Erin Lennox, Jens Praestgaard, Lucie Brujin, Peggy Allred, Ram Miller   +14 more
wiley   +1 more source

A Case-Study Based Course on Device Evaluation and FDA Approval

, 2008
Preclinical evaluation of new devices and therapies is an integral part of research and development in the medical device industry, and the regulatory process for FDA approval is a major driving force behind much that goes on in a company setting.
Cardinal, Kristen O\u27Halloran
core  

Early Recognition of Treatment‐Responsive Rapidly Progressive Dementia: The Modified STAM3mP Score

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Early identification of patients with treatment‐responsive rapidly progressive dementia (RPD) is important as early treatment improves outcomes. The STAM3P score identifies treatment‐responsive RPD using “high risk” presenting features. We optimized performance by adding a time component (i.e., dementia within 3 months) and validated the ...
R. W. van Steenhoven, N. Satyadev, A. E. M. Bastiaansen, Y. D. Piura, J. Kerstens, Y. S. Crijnen, J. Brenner, T. Brand, T. M. Bienfait, S. Veenbergen, J. M. de Vries, F. J. de Jong, E. G. P. Dopper, P. A. E. Sillevis Smitt, H. Seelaar, G. S. Day, M. J. Titulaer   +16 more
wiley   +1 more source