Imaging Diagnostic Systems announced the submission of its Premarket Approval Application (PMA) with the U.S. Food and Drug Administration (FDA), seeking marketing approval for its Computed Tomography Laser Mammography (CTLM) system.
The CTLM system visualizes the blood supply of tumors, without the use of x-rays and without breast compression. It is intended to be used as an adjunct to mammography, for women who have dense breasts and equivocal mammograms, where the CTLM system is designed to provide the radiologist with additional information to guide biopsy recommendations. If approved, the PMA will allow commercialization of CTLM systems throughout the United States, and should materially increase the Company's sales internationally.
Linda B. Grable, Chairman and Chief Executive Officer of Imaging Diagnostic Systems, commented, "This achievement is a culmination of efforts and dedication of many individuals devoted to making this non-invasive method of imaging breast cancer available to the medical community worldwide. We have reached a significant milestone in the history of our Company. If approved, this breakthrough technology could benefit millions of women."
Imaging Diagnostic Systems has received CE Marking, UL listing, ISO 9002 certification and FDA export certification for its CTLM system. Under the new Modular submission approach, the Company's PMA application has been divided into different modules, each of which contained specific information required for the FDA review process. The FDA has accepted the first four modules. The CTLM system is the first patented breast-imaging system that utilizes state of the art laser technology and patented algorithms to create 3-D cross sectional images of the breast. The CTLM system is a non-invasive, painless examination that does not expose the patient to radiation nor require breast compression.