The Radiological Devices Panel met on December 10, 2002, to discuss and vote on an original premarket approval (PMA) application, P010035 from Computerized Thermal Imaging, Inc. for their BCS 2100. The device produces a thermal image of the breast in women recommended for biopsy, and from this image the computer yields a result indicating whether or not the biopsy is still recommended.
Following a discussion of the issues associated with this PMA, the Panel's recommendation was "not approvable" by a 4 to 3 vote.
The consensus was that new trial data are needed because, from the clinical data presented, there were too many questions that remained unanswered to conclude that the device is safe and effective. The minority questioned whether a reanalysis of the existing data and/or a post-market study might help answer the outstanding questions.
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