CTI tries for incremental FDA approval

Computerized Thermal Imaging has submitted three of five data packages, or what the company is calling "modules," to the FDA as part of its premarket approval application for a breast cancer detection system that uses a heat sensitive camera.

The modules are data packages explaining to the FDA how the company's Computer Thermal Imaging system works. The system consists of a patient table and heat-sensitive camera and uses the company's proprietary computer algorithms.

The CTI camera can be used in conjunction with an x-ray mammography system, said Dee Rose, CTI spokesperson.

CTI was founded in 1987 by business partners who recognized that thermal imaging coupled with sophisticated software could differentiate healthy from suspicious tissue because of heat generated by the increased vascularity associated with tumors.

The firm believes that data generated by the CTI system can assist physicians in detecting the presence of numerous diseases, disorders, and injuries within the body's physiological, neurological, and vascular systems that conventional imaging systems such as x-ray, CT, or MR may miss.

The modules are being considered by the FDA in separate pieces. The first module was approved by the FDA at the end of last year. The second was submitted in February and is still under review.