FORT LAUDERDALE, Fla., Sept. 29 -- Imaging Diagnostic Systems Inc. has started a process in which it will gain US approval to market its Computed Tomography Laser Mammography (CTML) breast imaging system. The US Food and Drug Administration's Pre-Market Approval process will allow Imaging Diagnostic Systems to make random modular submissions of its data -- along with required documentation concerning safety and engineering requirements -- to the FDA for review and approval. This process will speed-up the imaging system's time to market because the company can make submission according to its own schedule, said Imaging Diagnostic Systems.
This is the most important event in our company's history to date, stated Richard Grable, CEO of Imaging Diagnostic Systems. It begins the culmination of everything that we have been working toward since we began IDSI. The management and I are excited that we have begun this important step toward receiving FDA approval for our proprietary CTLM.