Results 21 to 30 of about 333,056 (304)

Device and non-device patents listed on brand-name originator insulins at the time of approval.

, 2023
This figure shows the number of non-device patents (blue bars) and device patents (yellow bars) that manufacturers filed on their products before Food and Drug Administration (FDA) approval.
Ryan P. Knox (17403384), Aaron S. Kesselheim (7445897), Sean S. Tu (17403387), William B. Feldman (17403390), Anders Olsen (17369644), Reed F. Beall (9938994)   +5 more
core   +1 more source

Importance of interdisciplinary training for successful development of innovative biomedical implants

Current Directions in Biomedical Engineering, 2022
The development of novel and innovative biomaterials and biomedical devices like medical implants is a sophisticated task that requires expertise ranging from physicians over engineers and natural scientists to regulatory officers for clinical ...
Doll Katharina, Doll Patrick W., Doll Christian, Doll Theodor   +3 more
doaj   +1 more source

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

The role of the user within the medical device design and development process: Medical device manufacturers' perspectives [PDF]

, 2011
Copyright @ 2011 Money et al.Background: Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process ...
Jennifer L Martin, Money, AG, Young, Terry, Kuljis Jasna, Money Arthur G, Young, T, Martin, Jennifer L., Craven, Michael P., Martin Jennifer L, Julie Barnett, Terry Young, Barnett, J, Young Terry, Arthur G Money, Barnett, Julie, Kuljis, J, Craven Michael P, Michael P Craven, Kuljis, Jasna, Money, Arthur G., Barnett Julie, Craven, MP, Martin, JL, Jasna Kuljis   +23 more
core   +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

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

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