Imaging Diagnostic Systems Inc has received the letter of acceptance from the U.S. Food and Drug Administration (FDA) for Module 1 as part of the PreMarket Approval process. Module 1 contained a complete description of the CTLM system, its functional components and principles of operations. It also addressed safety issues related to the design of the CTLM system.
"This latest FDA development brings us closer to gaining marketing clearance and bringing this much needed device to the market," said John d' Auguste, Imaging Diagnostic System's President. "With this module approved, all efforts within the Company are now focused on completing the additional clinical studies and submitting the PreMarket Approval application."
Imaging Diagnostic Systems has received CE Marking, UL listing, ISO 9002 certification and FDA export certification permitting the Company to market its product internationally. The Company is seeking PreMarket Approval (PMA) from the Food and Drug Administration (FDA) for its CTLMâ 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 now submitted a total of four modules and is currently completing the PMA application as the final submission of the FDA approval process.