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Investigational Medical Device

Known as: Investigational Device 
A device that is the subject of clinical investigation or research to determine the safety or effectiveness of the device. Investigational devices… 
National Institutes of Health

Papers overview

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2013
2013
OBJECTIVE Sensitivity of a device based on Fluorescence Imaging with Reflectance Enhancement (FIRE) in detecting a potential… 
Review
2012
Review
2012
The U.S. Food and Drug Administration is now exerting its regulatory authority over the use of molecular diagnostics and related… 
Review
2012
Review
2012
Clinical investigators in academic medical centers often perceive federal regulations as a significant obstacle to conducting… 
2011
2011
A new hearing therapy based on direct acoustic cochlear stimulation was developed for the treatment of severe to profound mixed… 
Review
2011
Review
2011
The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for providing reasonable assurance of safety and… 
2010
2010
Study Design. This study was based on a post hoc analysis of data collected from a prospective FDA-regulated trial comparing… 
1992
1992
A multipurpose circulatory support system has been developed as both a temporary and permanent device in total artificial hearts…