Friday, March 17, 2006

FDA Approves Device for Detection of Cervical Pre-Cancer

The FDA issued a press release yesterday announcing its approval of an imaging system to improve detection of pre-cancerous cervical cells using light for women with abnormal Pap test results. Intended for use alongside colposcopy, the "LUMA Cervical Imaging System shines a light on the cervix and analyzes how different areas of the cervix respond to this light. The LUMA Systems assigns a score to tiny areas of the cervix and produces a color map that helps the doctor decide where to biopsy. The colors and patterns on the map help the doctor distinguish between healthy tissue, and potentially diseased tissue."

Additional information on the device is available here. The summary of safety and effectiveness, and labeling details, which the FDA requires for devices as well as drugs, are not yet available but will be at http://www.fda.gov/cdrh/pdf4/p040028.html when available.

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MeSH Tags: Diagnostic Imaging; Equipment and Supplies; Uterine Cervical Neoplasms/diagnosis; Vaginal Smears

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