# New Colon Scanner Approved



## Guest (Nov 22, 2000)

FDA Approvals: New Scanner for the Colon Laser device aims at pre-cancerous growths By Gary A. HoltHealthScout Reporter TUESDAY, Nov. 21 (HealthScout) -- Doctors often find it difficult to decide whether growths in the colon are harmless or have the potential to become cancerous. The Food and Drug Administration (FDA) gave pre-market approval this month for a new device that could help make a definite diagnosis. The Optical Biopsy System shines laser light on the suspicious growth, which absorbs the light energy and then emits light back to the device for analysis. System software indicates whether the growth is cause for concern. The FDA says the scanner is not intended to replace the judgment of the physician. Instead, it can provide an immediate reading to help a physician decide if a growth should be removed, eliminating the need for a second endoscopic procedure. Approval was based on clinical studies of safety and effectiveness and the recommendation of the Gastroenterology and Urology Devices Panel of the FDA's Medical Devices Advisory Committee. No adverse events were reported from use of the device. The Optical Biopsy System is made by SpectraScience, Inc. of Minneapolis. This press release explains the approval process and how the device will be marketed. -- Gary A. Holt has a Ph.D.in pharmacy and health


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## JeanG (Oct 20, 1999)

This is good news! Thanks 4willie.







JeanG


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