Results 11 to 20 of about 315,340 (245)

Generating the clinical evidence for an innovation in maternal and newborn health: The OdonAssist™ inflatable device for assisted vaginal birth

Revista Médica Clínica Las Condes, 2023
The OdonAssist™ inflatable device for assisted vaginal birth is an investigational device which underwent premarket clinical testing. The clinical evidence generation plan includes preclinical and clinical studies to support development, regulatory ...
Mario Merialdi
doaj   +1 more source

Generando evidencia clínica para una innovación en salud materna y neonatal: el dispositivo inflable OdonAssist™ para parto vaginal asistido

Revista Médica Clínica Las Condes, 2023
Resumen: El dispositivo inflable OdonAssist™ para parto vaginal asistido es un dispositivo de investigación que se sometió a pruebas clínicas previas a la comercialización.
Mario Merialdi
doaj   +1 more source

The future of glaucoma surgery

Journal of Ophthalmic & Vision Research, 2015
Glaucoma surgery is ripe for innovation. In the last few years, there has been a substantial increase in the number of devices approaching commercialization.
Arsham Sheybani
doaj   +1 more source

Correlation Between Conditional Approval and Customized Bone Implant Devices

Orthopaedic Surgery, 2019
This report aims to summarize key concerns regarding customized devices and conditional approval during the premarket evaluation of bone implants, and to explore the correlation between them.
Xiao‐lei Guo, Bin Liu, Zhong Lu
doaj   +1 more source

Characteristics of pivotal clinical trials of FDA-approved endovascular devices between 2000 and 2018: An interrupted time series analysis

Journal of Clinical and Translational Science, 2023
Background:The Food and Drug Administration (FDA) reviews safety, efficacy, and the quality of medical devices through its regulatory process. The FDA Safety and Innovation Act (FDASIA) of 2012 was aimed at accelerating the regulatory process for medical
John T. Moon, Menelaos Konstantinidis, Nevon Song, Nariman Nezami, Bill S. Majdalany, Allen Herr, Gary Siskin   +6 more
doaj   +1 more source

The Decline of Deep Brain Stimulation for Obsessive–Compulsive Disorder Following FDA Humanitarian Device Exemption Approval

Frontiers in Surgery, 2021
Background: In February 2009, the US Food and Drug Administration (FDA) granted Humanitarian Device Exemption (HDE) for deep brain stimulation (DBS) in the anterior limb of the internal capsule (ALIC) for the treatment of severely debilitating, treatment
Heather Pinckard-Dover, Heather Pinckard-Dover, Herbert Ward, Herbert Ward, Kelly D. Foote, Kelly D. Foote   +5 more
doaj   +1 more source

FDA, CE mark or something else?—Thinking fast and slow

Indian Heart Journal, 2017
There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time,
Sundeep Mishra
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

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

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