FDA Clearance

ViziLite Oral Lesion Identification System

In November of 2001, the U.S. Food and Drug Administration cleared ViziLite as an adjunct to visual examination of the oral cavity.  It remains the only medical device for this application cleared for use in a population at increased risk for oral cancer.  This is the same technology that has been used since 1995 for the identification of abnormalities in stratified squamous epithelium.

Chemiluminescent light technology was originally tested on 13,000 cervical cancer patients and obtained FDA clearance for use as a visual screening device for cervical cancer.  Clinical research demonstrated that the illumination device doubled cervical cancer detection. It is the same technology used in ViziLite.

TBlue⁶³⁰ Oral Lesion Marking System

In January of 2005 the U.S. Food and Drug Administration cleared the TBlue⁶³⁰ oral lesion marking system as an adjunctive technology for use with the ViziLite oral lesion identification system.