Monday, February 1, 2010 :: IMAGING DIAGNOSTIC SYSTEMS RECEIVES AUSTRALIAN TGA APPROVAL TO MARKET ITS CTLM
IMAGING DIAGNOSTIC SYSTEMS RECEIVES AUSTRALIAN TGA APPROVAL TO MARKET ITS CTLM
Fort Lauderdale, Florida, February 1, 2010—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS), a pioneer in laser optical breast imaging, announced today that the Australian Government Department of Health and Ageing Therapeutic Goods Administration has approved the CT Laser Mammography (CTLM®) system for inclusion on the Australian Register of Therapeutic Goods (ARTG). The Therapeutic Goods Administration (TGA) must approve the inclusion of all medical devices on the Register before devices can be sold in Australia.
“Gaining approval in Australia is an important step for us. It enables us to reach the Australian market and to perhaps influence related markets,” stated Deborah O’Brien, IDSI’s Senior Vice President. “We are very pleased with the work that our distributor has been doing in this market and anticipate many new developments from this approval.”
Approval was obtained through the efforts of Jainsons Pty Ltd., the official distributor of the CTLM system in Australia. Jainsons will now work to introduce the system to the Australian market through commercial and clinical exhibitions, advertising, and the development of clinical studies and partnerships.
“Australia TGA approval will open the well-informed and educated Australian market to the CTLM system,” commented Dr. Mukesh Jain, Chairman and CEO of Jainsons. “Once CTLM technology has been introduced and accepted in Australia, the possibility of penetrating Asian countries also emerges, as approval in Australia is of international significance. TGA approval for the CTLM system is indeed a great achievement for IDSI and Jainsons, one that will open new doors for the marketing of this technology.”
About Imaging Diagnostic Systems, Inc.
Imaging Diagnostic Systems, Inc. has developed a revolutionary new imaging device to aid in the detection and management of breast cancer. The CTLM® system is a breast imaging system that utilizes patented continuous wave laser technology and computer algorithms to create 3-D images of the breast. The procedure is non-invasive, painless, and does not expose the patient to ionizing radiation or painful breast compression. CT Laser Mammography (CTLM®) is designed to be used in conjunction with mammography. It reveals information about blood distribution in the breast and may visualize the process of angiogenesis, which usually accompanies tumor growth.
The Company is currently undergoing the clinical studies required for the Premarket approval application. The FDA has determined that the Company’s clinical study is a non-significant risk (NSR) investigational device study under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The CTLM system is limited by United States Federal Law to investigational use only in the United States.
For more information, visit our website: www.imds.com
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