Imaging Diagnostic Systems Inc is exhibiting its Computed Tomography Laser Mammography system (CTLM) at Breast Imaging 2001 in Venice, Italy, through the end of this week. The Conference is intended to provide the medical community with the innovations of breast cancer prevention and treatment, including new modalities such as digital mammography and digital ultrasound, and explore the potential of three-dimensional imaging.
It was stated that the CTLM is intended as an adjunctive diagnostic imaging device after a screening mammogram to provide the physician with additional information about a suspicious area. X-ray mammography is the current accepted screening modality for breast imaging examination.
Imaging Diagnostic Systems is seeking Pre-Market 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 submitted two modules and is currently completing the next set of modules to be submitted.