Results 31 to 40 of about 333,056 (304)

How does medical device regulation perform in the United States and the European union? A systematic review.

PLoS Medicine, 2012
BackgroundPolicymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems.
Daniel B Kramer, Shuai Xu, Aaron S Kesselheim   +2 more
doaj   +1 more source

Regulatory approval for autologous human cells and tissue products in the United States, the European Union, and Japan

Regenerative Therapy, 2015
Human cells and tissue products belong to a relatively new class of medical products. Therefore, limited information is available on the classification and premarket evaluation of human cells and tissue products in the United States (US), the European ...
Kazuo Yano, Natsumi Watanabe, Kenichiro Tsuyuki, Taisuke Ikawa, Hiroshi Kasanuki, Masayuki Yamato   +5 more
doaj   +1 more source

Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA

Trials, 2021
Background Selective registration, publication, and outcome reporting of clinical trials distort the primary clinical evidence that is available to patients and clinicians regarding the safety and efficacy of US Food and Drug Administration (FDA ...
Matthew J. Swanson, James L. Johnston, Joseph S. Ross   +2 more
doaj   +1 more source

Mobility and freedom of movement: A novel out-of-hospital treatment for pediatric patients with terminal cardiac insufficiency and a ventricular assist device

Frontiers in Cardiovascular Medicine, 2022
BackgroundDue to rapid medical and technological progress, more and more pediatric patients with terminal cardiac insufficiency are being implanted with a ventricular assist device as a bridge to transplant without legal approval for hospital discharge ...
Kathrin Rottermann, Sven Dittrich, Oliver Dewald, Andreas Teske, Nicola Kwapil, Steffen Bleck, Ariawan Purbojo, Frank Münch   +7 more
doaj   +1 more source

Design and analysis of crossover trials for investigating high-risk medical devices: A review

Contemporary Clinical Trials Communications, 2022
During evaluation of new investigational medical devices, the FDA recommends that investigators design a crossover clinical trial, in which the patients are arranged to cross over from one treatment arm to another. The FDA annually receives the premarket
Bo Zhang, Jing Guo, Hui Zhang
doaj   +1 more source

Bottlenecks to Clinical Translation of Direct Brain-Computer Interfaces

Frontiers in Systems Neuroscience, 2014
Despite several decades of research into novel brain-implantable devices to treat a range of diseases, only two- cochlear implants for sensorineural hearing loss and deep brain stimulation for movement disorders- have yielded any appreciable clinical ...
Mijail Demian Serruya
doaj   +1 more source

Safety and effectiveness of bycross rotational atherectomy and aspiration device: a prospective, multi-center pre-market approval study

CVIR Endovascular, 2023
Purpose To demonstrate safety and effectiveness of the novel ByCross® atherectomy system for treatment of complex femorodistal > 80% arterial stenosis.
Jörg Tessarek, Ralf Kolvenbach
doaj   +1 more source

Know Before You Apply : Summarized Quality Requirements Needed to Achieve NIOSH Approval [PDF]

"The NIOSH Respirator Approval Program frequently receives questions from manufacturers, distributors, and designers related to NIOSH respirator approval applications.

core   +1 more source

Editorial Perspective: How should child psychologists and psychiatrists interpret FDA device approval? Caveat emptor [PDF]

, 2016
Recently several new tests have received US Federal Drug Administration (FDA) marketing approval as aids in the diagnostic process for attention deficit hyperactivity disorder (ADHD), including the Neuropsychiatric electroencephalogram (EEG)-Based ADHD ...
Loo, Sandra K., Arns, Martijn, Asherson, Philip, Arns, Martijn; id_orcid, Kuntsi, Jonna; id_orcid, Brandeis, Daniel, Kuntsi, Jonna, Banaschewski, Tobias, Loo, Sandra K, Sterman, M. Barry, Heinrich, Hartmut, Sterman, M Barry, Asherson, Philip; id_orcid   +12 more
core   +1 more source

Bronchial thermoplasty-an update

Annals of Thoracic Medicine, 2018
Bronchial Thermoplasty is a procedure that involves the delivery of radiofrequency energy during bronchoscopy to airways in order to selectively ablate airway smooth muscles.
Faria Nasim, Vivek N Iyer
doaj   +1 more source