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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…
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National Institutes of Health
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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.
B. Amaechi
,
I. Chedjieu
,
Juanita Lozano-Pineda
The Journal of Clinical Dentistry
2013
Corpus ID: 20850650
OBJECTIVE Sensitivity of a device based on Fluorescence Imaging with Reflectance Enhancement (FIRE) in detecting a potential…
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Review
2013
Review
2013
"Off-label" use of orthopedic implants in the wrist.
W. Cooney
Journal of Hand Surgery-American Volume
2013
Corpus ID: 29619315
Review
2012
Review
2012
Lessons Learned from the Investigational Device Exemption Review of Children's Oncology Group Trial AAML1031
S. Meshinchi
,
S. Hunger
,
R. Aplenc
,
P. Adamson
,
J. Jessup
Clinical Cancer Research
2012
Corpus ID: 20845404
The U.S. Food and Drug Administration is now exerting its regulatory authority over the use of molecular diagnostics and related…
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Review
2012
Review
2012
Understanding Food and Drug Administration Regulatory Requirements for an Investigational Device Exemption for Sponsor-Investigators
M. E. Blair Holbein
,
Jelena Petrovic Berglund
Journal of Investigative Medicine
2012
Corpus ID: 30976012
Clinical investigators in academic medical centers often perceive federal regulations as a significant obstacle to conducting…
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2011
2011
Design of a Semi-Implantable Hearing Device for Direct Acoustic Cochlear Stimulation
H. Bernhard
,
C. Stieger
,
Y. Perriard
IEEE Transactions on Biomedical Engineering
2011
Corpus ID: 6788399
A new hearing therapy based on direct acoustic cochlear stimulation was developed for the treatment of severe to profound mixed…
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Review
2011
Review
2011
Performing clinical studies involving hernia mesh devices: what every investigator should know about the FDA investigational device exemption (IDE) process
B. Ashar
,
J. Dang
,
D. Krause
,
M. Luke
Hernia
2011
Corpus ID: 5633557
The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for providing reasonable assurance of safety and…
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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
D. Ohnmeiss
,
William Bodemer
,
J. Zigler
Spine
2010
Corpus ID: 205513056
Study Design. This study was based on a post hoc analysis of data collected from a prospective FDA-regulated trial comparing…
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Review
2004
Review
2004
A cardiologist in the carotids.
W. Gray
Journal of the American College of Cardiology
2004
Corpus ID: 25033702
2003
2003
Development and evaluation of investigational vena caval filters: the complementary roles of in vitro and in vivo studies.
M. Proctor
,
K. Cho
,
L. Greenfield
Journal of Surgical Research
2003
Corpus ID: 27135209
1992
1992
Baylor multipurpose circulatory support system for short- to long-term use.
M. Shiono
,
S. Takatani
,
+7 authors
M. Debakey
ASAIO journal ()
1992
Corpus ID: 21103432
A multipurpose circulatory support system has been developed as both a temporary and permanent device in total artificial hearts…
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