Imaging Diagnostic Systems, Inc., FT Lauderdale, Fla, has received approval from the Australian government’s Australian Register of Therapeutic Goods (ARTG) for its newCT Laser Mammography (CTLM®) system.
Similar to the FDA in the United States, the approval by the ARTG allows Imaging Diagnostics Systems Inc (IDSI) to move forward with marketing the CTLM system in Australia.
The CTLM system is a breast imaging system that utilizes proprietary 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 breast compression. The system is designed to be used in conjunction with mammography, and can reveal information about blood distribution in the breast and visualize angiogenesis, which usually accompanies tumor growth.
“Gaining approval in Australia is an important step for us. It enables us to reach the Australian market and to perhaps influence related markets,” said Deborah O’Brien, IDSI’s senior vice president.
IDSI now intends to bring the product to other parts of Asia, as well as to the United States. Currently, however, the CTLM system is limited to investigational use only in the United States.
For more information, visit www.imds.com.