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Article: CTI gets 'non-approvable' letter on breast imaging, may appeal.
- Article from:
- Medical Device Daily
- Article date:
- January 29, 2003
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CTI gets non-approvable letter on breast imaging, may appeal
By KAREN YOUNG
Medical Device Daily Staff Writer
Computerized Thermal Imaging (CTI; Portland, Oregon) has taken a blow from the FDA, which said in a letter to the company that its premarket approval (PMA) application for its thermal breast imaging system is not approvable a decision CTIs president and chief operating officer said the company may appeal.
The FDA decision followed a recommendation by the Radiological Devices Panel of the Center for Devices and Radiological Health on Dec. 10 not to approve the application.
What it means at this point is that the system ...