LAYTON, Utah, Feb. 11 -- Computerized Thermal Imaging Inc. (CTI) has submitted its second data package to the US Food and Drug Administration as part of its application for pre-market approval of the company's breast cancer detection system. CTI seeks FDA approval for the use of its Computerized Thermal Imaging System as a diagnostic test to be used in conjunction with the mammogram and clinical examination for the detection of breast cancer. The package submitted for agency approval contains design information on the CTI system.
The system employs a heat-sensitive camera to record thermal images of breast tissue, which are processed using proprietary computer algorithms. The test, which the company described as simple and painless, does not involve radiation, breast compression, electrodes or electrical current.