IDSI receives FDA additional information request regarding CTLM imaging device 510(k) application

Imaging Diagnostic Systems, Inc., (IDSI) (OTCBB: IMDS) a pioneer in laser breast imaging, announced today that it has received notification from the Food and Drug Administration ( FDA) requesting additional information of its 510 (k) application in order to complete their review.

"The request for additional information is quite common during the FDA review process. The information allows the FDA to have a clearer understanding of the unique clinical features of our Computed Tomography Laser Mammography (CTLM) imaging device. Currently, we are working with our FDA Regulatory Advisors to respond in a timely manner. However, while the FDA is waiting for the information, the application is considered "pending" and is placed on hold until the information is received," stated Linda Grable CEO/Imaging Diagnostic Systems.