Imaging Diagnostic Systems Inc has installed its CTLM system into the Instituto Nacional de Cancerologia, the foremost Cancer Institute in Mexico. Founded in 1946, Instituto Nacional de Cancerologia is known as the best Oncologic Center in the country. In 1980 the hospital was recognized as the most prestigious Institution in Latin America, USA and Europe.
Dr. Yolanda Villasenor, Chief Radiologist of the Breast Cancer Center at Instituto Nacional de Cancerologia, will assist the Company in obtaining additional clinical data to further substantiate the Company's Pre-Market Approval (PMA) application, facilitate the clinical atlas, and serve as a promotional site for future sales prospects. Dr. Villasenor along with 20 other renowned Mexican radiologists, surgeons and pathologists are considered "opinion leaders" in the breast cancer field for Mexico and Latin America.
"The placement of our CTLM system in this renowned cancer institute will serve as a platform for introducing our technology to Latin America. We're honored to be working with such a highly esteemed group of doctors in Mexico and are grateful for the opportunity to collect valuable clinical patient data from these studies to assist in our FDA approval process," stated Linda B. Grable, CEO/Chariman of Imaging Diagnostic Systems Inc.
Imaging Diagnostic Systems has received CE Marking, UL listing, and ISO 9002 certification permitting the Company to market its product internationally. The Company is seeking PreMarket Approval (PMA) from the Food and Drug Administration (FDA) for its CTLM system to be used as an adjunct to mammography to aid in the detection of breast abnormalities. Under the new Modular submission approach, the Company's PMA application has been divided into different modules, each of which will contain documentation required for the FDA review. The company has now submitted a total of four modules out of five that are required for the FDA approval process.