BRITISH COLUMBIA, Canada--LED Dental Inc., a Vancouver-based medical device company, has announced that its VELscope Oral Mucosal Examination System can now display the CE Mark for authorized distribution within the European Union.
Specifically, LED Dental Inc. was awarded an EC Certificate by an independent notified body. This certification signifies that VELscope meets the essential requirements of the European Medical Device Directive and that LED Dental's quality assurance system conforms to the guidelines for medical devices agreed upon and set by the 28 member states of the European Economic Area.
VELscope was clinically proven by leading U.S. and Canadian cancer researchers to be an effective adjunctive screening instrument for detecting abnormal areas of concern such as potentially cancerous lesions, which are often undetectable by the naked eye under white light.
"This is a very important and exciting milestone," said LED Dental Inc. president Wayne Rees. "This is our first step towards marketing and distributing VELscope in Europe and providing EEA member countries with the new standard of care for early detection in oral mucosal screening."
