Results 61 to 70 of about 454,812 (304)

Design and development of a novel Invasive Blood Pressure simulator for patient's monitor testing [PDF]

, 2020
This paper presents a newly-designed and realized Invasive Blood Pressure (IBP) device for the simulation on patient’s monitors. This device shows improvements and presents extended features with respect to a first prototype presented by the authors and ...
Bibbo, Daniele, Kijonka, Jan, Kudrna, Petr, Penhaker, Marek, Vávra, Petr, Zonča, Pavel   +5 more
core   +1 more source

Prediction of Myasthenia Gravis Worsening: A Machine Learning Algorithm Using Wearables and Patient‐Reported Measures

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Background Myasthenia gravis (MG) is a rare disorder characterized by fluctuating muscle weakness with potential life‐threatening crises. Timely interventions may be delayed by limited access to care and fragmented documentation. Our objective was to develop predictive algorithms for MG deterioration using multimodal telemedicine data ...
Maike Stein, Haoqi Sun, Sophie Lehnerer, Lea Gerischer, Maximilian Mönch, Christian Meisel, Andreas Meisel, Pushpa Narayanaswami   +7 more
wiley   +1 more source

Regulatory Requirements and Considerations of Aesthetic Injection Medical Devices in China, the USA and the European Union

Zhongguo yiliao qixie zazhi
This study summarizes the marketing access and regulatory requirements of aesthetic injection medical devices in China, the USA, and the European Union (EU), and conducts a comparative analysis of the regulatory similarities and differences among these ...
Shan DONG, Xiangmei ZHANG
doaj   +1 more source

Lessons Learned From a Delayed‐Start Trial of Modafinil for Freezing of Gait in Parkinson's Disease

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Objective Freezing of gait (FOG) in people with Parkinson's disease (PwPD) is debilitating and has limited treatments. Modafinil modulates beta/gamma band activity in the pedunculopontine nucleus (PPN), like PPN deep brain stimulation. We therefore tested the hypothesis that Modafinil would improve FOG in PwPD.
Tuhin Virmani, Lakshmi Pillai, Reid D. Landes, Aliyah Glover, Shannon Doerhoff, Jennifer Kleiner, Mitesh Lotia, Rohit Dhall, Edgar Garcia‐Rill   +8 more
wiley   +1 more source

Transformation of European Medical Device Regulation: The role of expert panels [PDF]

Pharmacia
The European Medical Device Regulation (MDR) (EU 2017a) and In Vitro Diagnostic Regulation (IVDR) (EU 2017b) represent a transformative shift in medical device oversight, replacing outdated directives with comprehensive safety and transparency ...
Iana Simova, Valentina Petkova, Sava Ognyanov, Milen Dimitrov   +3 more
doaj   +3 more sources

Regulating Innovative Medicine: Fitting Square Pegs in Round Holes [PDF]

, 2005
Increasingly, innovative medical products are creating a quandary for the Food and Drug Administration ( FDA ) because they often transcend the FDA\u27s traditional categorical approach to regulating medical products. In a recent attempt to simplify this
Lavender, Mark
core   +1 more source

Life‐Threatening Bradycardia in Anti‐NMDA‐Receptor Encephalitis and a Novel Use for Permanent Pacing

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Background Pediatric anti‐NMDA receptor encephalitis (pNMDARE) is an autoantibody‐mediated disorder that can cause severe autonomic dysfunction, including symptomatic bradycardia and asystole. Dysautonomia can last for years, making it very challenging to manage.
Sarah Tucker, Abhijit Das, Andres Jimenez, Areeba Basit, Yike Jiang, Emily A. Smitherman, Heather Van Mater, Taylor Howard, Alexander J. Sandweiss, Kristen S. Fisher   +9 more
wiley   +1 more source

Liability in the medical sector : the ‘breast-taking’ consequences of the poly implant prothese case [PDF]

, 2016
The article deals with the liability of third-party certifiers in the medical sector and especially focuses on the role of TuV Rheinland in the recent Poly Implant Prothese (PIP) breast implant case. The aim of the contribution is twofold.
De Bruyne, Jan, Vanleenhove, Cedric
core  

Impact of Asymptomatic Intracranial Hemorrhage on Outcome After Endovascular Stroke Treatment

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Background Endovascular treatment (EVT) achieves high rates of recanalization in acute large‐vessel occlusion (LVO) stroke, but functional recovery remains heterogeneous. While symptomatic intracranial hemorrhage (sICH) has been well studied, the prognostic impact of asymptomatic intracranial hemorrhage (aICH) after EVT is less certain ...
Shihai Yang, Chengsong Yue, Zhuang Li, Xiaolei Shi, Haoxuan Zhu, Jie Yang, Linyu Li, Jiaxing Song, Shitao Fan, Gaoming Li, Wenzhe Sun, Zhixian Ye, Jiacheng Huang, Dahong Yang, Jinfu Ma, Xu Xu, Zhixi Wang, Lilan Wang, Guojian Liu, Fengli Li, Changwei Guo, Li Qi, Wenjie Zi   +22 more
wiley   +1 more source

Die Pathologie im Rahmen des europäischen und nationalen Medizinprodukterechts: Betrieb, Anwendung und Eigenherstellung von In-vitro-Diagnostika

GMS German Medical Science
Institutes for pathology act as operators, users and in-house manufacturers of in vitro diagnostic medical devices and are subject to national and European regulations depending on their function.
Kahles, Andy, Goldschmid, Hannah, Volckmar, Anna-Lena, Kazdal, Daniel, Gassner, Ulrich M., Vogeser, Michael, Brüggemann, Monika, Bürrig, Karl-Friedrich, Kääb-Sanyal, Vanessa, Flechtenmacher, Christa, Schirmacher, Peter, Stenzinger, Albrecht   +11 more
doaj   +1 more source