LUMA™ Cervical Imaging System Received USDA PMA

Filed in archive Diagnostics , News by Gloria Gamat on March 17, 2006

MediSpectra, Inc. received USFDA approval for its PMA (premarket approval) application for LUMA™ Cervical Imaging System, the first optical imaging device approved as an aid to clinicians examining women with abnormal Pap tests. This non-contact optical imaging device is expected to reduce the number of high-grade cervical cancer precursors when used as an adjunct to colposcopy.

The LUMA™ system scans tissue with a combination of fluorescence spectroscopy, white light diffuse reflectance spectroscopy, and video imaging. A complete scan takes 12 seconds, with results available to the clinician during the examination. The LUMA™ system is the only FDA-approved optical device designed to evaluate the cervix as an aid in the early detection of high-grade cervical cancer and its precursors.

The LUMA™ system is a significant step forward for early detection and treatment of cervical cancer and its precursors.The launch of this product will be the first in a series of new technologies that will truly help to save lives and significantly improve the practice of women's healthcare.

Read the complete press release at MedicSpectra and USFDA.

Photo Credit: www.cancercare.mb.ca

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