| Thursday, July 29, 2010 | |||
| NEWSRoom | |||
| 04/17/2001 | |||
| Source: Imaging Diagnostic Systems, Inc. | |||
Imaging Diagnostic Systems Exhibits CTLM(R) at Breast Imaging 2001 |
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Rate It! Richard Grable, CEO of IDSI and inventor of the CTLM(R), had stated that the CTLM(R) is intended to be used 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(R) 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. Imaging Diagnostic Systems, Inc., has developed the world's first patented laser-based breast imaging system that utilizes state-of-the-art laser technology and proprietary and patented algorithms to create three-dimensional cross sectional images of the breast. The CTLM(R) is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression. |
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