IDSI submits Premarket Notification for CTLM breast imaging device to FDA

Imaging Diagnostic Systems, Inc., (IDSI) (OTCBB: IMDS) a pioneer in laser breast imaging, announced today that a Premarket Notification 510(k) was submitted on Monday, November 22, 2010, to the United States Food and Drug Administration (FDA). With this submission, the company moves forward in the process of seeking marketing clearance for its innovative breast imaging device, the CTLM system.

“CTLM has the potential to be a significant addition to breast imaging facilities, especially in difficult cases, like patients with dense breasts. We are committed to getting this product to market as quickly as possible, while simultaneously developing strong distribution channels and marketing resources for its launch.”

The CTLM system is an innovative breast imaging device intended to aid in the diagnosis of breast cancer in a non-invasive procedure. The patient lies face down comfortably on the scanning bed for approximately 10 minutes until the scan is completed. CTLM uses state-of the-art laser technology and proprietary computed algorithms instead of x-rays and breast compression to create three-dimensional views of the blood supply in the breast. These images can be used to complement current breast imaging modalities, providing additional information on the nature of breast abnormalities.

"This submission is a significant step toward the realization of our dream of marketing this unique breast imaging device throughout the United States," stated Linda Grable, CEO of Imaging Diagnostic Systems. "CTLM has the potential to be a significant addition to breast imaging facilities, especially in difficult cases, like patients with dense breasts. We are committed to getting this product to market as quickly as possible, while simultaneously developing strong distribution channels and marketing resources for its launch."

As breast cancer is the most common cancer in women worldwide, the emphasis on breast cancer screening and detection has steadily increased. According to the World Health Organization, survival rates vary widely throughout the world, from more than 80 percent in the United States, Sweden, and Japan, to under 40 percent in poorer countries. In the face of these statistics, along with the benefits that the CTLM system offers to women and their physicians, the system is rapidly gaining international recognition.

Imaging Diagnostic Systems will continue to market the CTLM system and to work with its international clinical sites, where the system has gained approval. The documentation and the data submitted to the FDA will now officially enter the 510(k) review process.

The CTLM system has received certification and licenses European CE marking, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification.