Results 1 to 10 of about 333,056 (304)

Considerations and Recommendations for the Introduction of Objective Performance Criteria for Transcatheter Aortic Heart Valve Device Approval

Circulation, 2016
In the United States, new surgical heart valves can be approved on the basis of objective performance criteria (OPC). In contrast, the US Food and Drug Administration traditionally requires stricter criteria for transcatheter heart valve (THV) approval ...
Stuart J Head, Michael J Mack, Nicolò Piazza   +2 more
exaly   +3 more sources

First in man evaluation of a novel circulatory support device: Early experience with the Impella 5.5 after CE mark approval in Germany

Journal of Heart and Lung Transplantation, 2021
Evgenij Potapov, David Schibilsky, Carsten Tschope   +2 more
exaly  

Device Approved for Adults With Nightmare Disorder

JAMA, 2020
openaire   +2 more sources

A Record Year for Device Approvals

JAMA, 2019
openaire   +2 more sources

New Device Approvals

Biomedical Safety & Standards, 2007
openaire   +1 more source

Research And The Drug/Device Approval Process

1998
Abstract All medical research is designed to answer scientific and clinical questions, but some is also designed to play a role in securing approval from a regulatory agency to produce and sell a drug or a medical device. Research designed to play that role must meet the ethical standards discussed in Chapters One through Six for all ...
openaire   +1 more source

Speeding Device Approval

JAMA, 2012
openaire   +1 more source

Femoral closure devices: Seal of approval

Catheterization and Cardiovascular Interventions, 2001
openaire   +2 more sources

FDA device approval regulations

Human Pathology, 1994
openaire   +1 more source

FDA Approves New Devices

Journal of Clinical Engineering, 2011
openaire   +1 more source