Computerized Thermal Imaging Inc. (CTI) received a Medical Device License from Health Canada to market its BCS2100 breast cancer imaging system in Canada.
The BCS2100 uses infrared thermal imaging (IR) technology as an adjunct device to assist doctors in the early detection and discrimination of breast cancer. The process is designed to be quick, painless, non-invasive, and requires no patient exposure to radiation, breast compression or electrical current.
As part of the license approval, CTI was required to be certified to the international quality system requirements for medical devices -- ISO 13485 -- and be audited by a recognized registrar for compliance with the Canadian Medical Devices Conformity Assessment System (CMDCAS), which was completed in October of 2003.
CTI's Thermal Image Processor (TIP) is the core imaging device within the BCS 2100. CTI has placed or sold more than 120 TIP systems worldwide.