FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--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.
About Imaging Diagnostic Systems, Inc
The CTLM system is a laser based breast imaging system intended to provide the physician with physiological and clinical information non-invasively and without the use of ionizing radiation. The patient lays face down in the prone position comfortably on the scanning bed. The laser beam sweeps 360 degrees starting at the chest wall moving forward until the entire breast is scanned. The CTLM features 3-dimensional and Multiplanar views that display the distribution of blood supply within the vasculature structures of the breast. This information when interpreted by a trained radiologist can be useful in diagnostic determination.
The CTLM system has received certification and licenses to sell internationally European CE marking, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification. The company’s traditional 510(k) application is pending review from the Food and Drug Administration for marketing clearance in the United States.
For more information, visit our website: http://www.imds.com.
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