CE Mark for Imaging Diagnostic Systems

This system utilizes laser technology and patented algorithms to create 3-D cross-sectional images of the breast in a noninvasive exam that does not expose the patient to radiation or require breast compression.

Imaging Diagnostic Systems is seeking approval of the U.S. Food and Drug Administration (FDA) for the CTLM system to be used as an adjunct to mammography and for clinical examination to aid the detection of breast abnormalities. Under the FDA's new modular submission approach, the company's application has been divided into different modules. Two modules have been submitted for FDA review, and the company anticipates finalizing the submission process by early 2001.

"We are now beginning the transition from a development-stage company to an operational company with revenues,” said Linda Grable, president of Imaging Diagnostic Systems.



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