This article was originally published in The Gray Sheet
Executive SummaryStudy results to be presented at FDA's May 17 panel meeting on the Luma spectroscopy-based cervical imaging system will include data from 2,526 women - not 2,200, as reported by "The Gray Sheet" (April 18, 2005, p. 8) - in addition to findings from a 604-patient pilot trial. PMA approval is being sought as a colposcopy adjunct, not replacement, MediSpectra clarifies. [Editors' note: To order a DVD or videotape of this meeting, please visit 1FDAAdvisoryCommittee.com or call 800-627-8171]...
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