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investigational device exemption

   Also found in: Dictionary/thesaurus, Acronyms, Encyclopedia, Wikipedia, Hutchinson 0.02 sec.
investigational device exemption (IDE)
[inves′tigā′shənəl]
Etymology: L, investigare, to search for
an agreement through which the federal government permits the testing of new medical devices.


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Within the next few months, Radiance intends to file for an Investigational Device Exemption ("IDE") with the United States Food and Drug Administration ("FDA") to expand the enrollment in the United States to begin a Phase I Study.
The device was first introduced in November 2004 and began its FDA-approved investigational device exemption study in the United States this spring.
WASHINGTON -- Corindus, developer and marketer of proprietary remote control catheterization systems, announced today that it filed its Investigational Device Exemption (IDE) application for the CORRECT (Coronary Remote Control Catheterization Trial) clinical trial at the Cardiovascular Research Foundation's eighteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.
 
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