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MediSpectra’s Luma gains PMA approval

This article was originally published in The Gray Sheet

Executive Summary

A cervical imager that works to identify pre-cancerous cells won PMA approval March 16 from FDA, overcoming last May's 9-2 vote against approving the device from the agency's Obstetrics & Gynecology Devices advisory panel based on concerns about the device's high false positive rate (1"The Gray Sheet" May 23, 2005, p. 11). MediSpectra says when used in conjunction with colposcopy, Luma - the first optical imaging device approved as an aid to clinicians examining women with abnormal Pap tests - identifies sites on the cervix that may contain pre-cancerous cells. FDA's approval was based on data from a study of 193 women that showed Luma detected additional cancer precursors missed by colposcopy...
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