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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

Semantic Scholar uses AI to extract papers important to this topic.
2013
2013
Clinical evaluation of an enhanced white light and fluorescence device for early detection of caries lesions.
OBJECTIVE Sensitivity of a device based on Fluorescence Imaging with Reflectance Enhancement (FIRE) in detecting a potential… 
Review
2013
Review
2013
"Off-label" use of orthopedic implants in the wrist.
Review
2012
Review
2012
Lessons Learned from the Investigational Device Exemption Review of Children's Oncology Group Trial AAML1031
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
Understanding Food and Drug Administration Regulatory Requirements for an Investigational Device Exemption for Sponsor-Investigators
Clinical investigators in academic medical centers often perceive federal regulations as a significant obstacle to conducting… 
2011
2011
Design of a Semi-Implantable Hearing Device for Direct Acoustic Cochlear Stimulation
A new hearing therapy based on direct acoustic cochlear stimulation was developed for the treatment of severe to profound mixed… 
Review
2011
Review
2011
Performing clinical studies involving hernia mesh devices: what every investigator should know about the FDA investigational device exemption (IDE) process
The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for providing reasonable assurance of safety and… 
2010
2010
Effect of Adverse Events on Low Back Surgery Outcome: Twenty-Four-Month Follow-up Results From a Food and Drug Administration Investigational Device ExemptionTrial
Study Design. This study was based on a post hoc analysis of data collected from a prospective FDA-regulated trial comparing… 
Review
2004
Review
2004
A cardiologist in the carotids.
2003
2003
Development and evaluation of investigational vena caval filters: the complementary roles of in vitro and in vivo studies.
1992
1992
Baylor multipurpose circulatory support system for short- to long-term use.
A multipurpose circulatory support system has been developed as both a temporary and permanent device in total artificial hearts… 
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