LAYTON — Computerized Thermal Imaging Inc. has submitted the fourth of five required modules to the U.S. Food and Drug Administration in connection with the company's application for pre-market approval for its thermal breast imaging system.
The administration has approved two of the modules, needed as the company seeks FDA approval to use its breast imaging system as an adjunct to mammography and clinical examination in the detection of breast cancer. The company's system uses a heat-sensitive camera to get thermal images of breast tissue, which are processed by proprietary computer algorithms. The process is designed to be quick, painless and non-invasive.
The fourth module contains information on nonclinical testing such as bio-compatibility testing, electrical safety, electromagnetic compatibility, environmental assessment, reliability and durability, and stress and wear.