FORT LAUDERDALE, Fla., Oct. 10 -- Imaging Diagnostic Systems Inc. has installed its CTLM system into the Instituto Nacional de Cancerologia Cancer Institute in Mexico. Imaging Diagnostic’s breast imaging system employs state-of-the-art laser technology and proprietary and patented algorithms to create three-dimensional cross-sectional images of the breast.
Yolanda Villasenor, chief radiologist of the Breast Cancer Center at Instituto Nacional de Cancerologia, will assist Imaging Diagnostics to obtain clinical data to further substantiate its Pre-Market Approval (PMA) application, facilitate the clinical atlas, and be a promotional site for sales prospects.
``The placement of our CTLM system in this renowned cancer institute will serve as a platform for introducing our technology to Latin America,'' said Imaging Diagnostic Systems CEO Linda B. Grable.
Imaging Diagnostics has received CE Marking, UL listing, and ISO 9002 certification in order to market its product internationally. It is seeking a PMA from the Food and Drug Administration (FDA) in order for its CTLM system to be used as an adjunct to mammography in detecting breast abnormalities. The company's PMA application has been divided into different modules, each of which will contain documentation required for the FDA review. It has now submitted four out of the five modules required for the FDA approval process.