The Australian TGA cancelled IMDS's approval to sell the CTLM in the country after a scathing article was written by the Cancer Council of western Australia
this is an Australian Government website Unproven breast imaging technologies – the facts Unproven breast imaging technologies are aggressively marketed in Western Australia, particularly to young women. They are often promoted as an alternative to mammography, the screening tool for breast cancer. This factsheet provides information about the unproven breast imaging technologies that are commercially available in Western Australia. These include: ? Electrical impedance ? Computerised/mechanical breast imaging (CBI) ? Thermography ? Computed Tomography Laser Mammography (CTLM) Concerns The promotion of unproven breast imaging technologies has raised concerns among health professionals and cancer experts, as there is little or no scientific evidence to demonstrate that these technologies reduce deaths from breast cancer. In fact, none of these technologies are approved for use in Australia as stand alone tests for breast cancer detection – they are only approved for use in conjunction with scientifically proven breast imaging techniques such as mammography. Breast imaging technologies are commercially available because they have been approved for use by the Therapeutic Goods Administration (TGA). However, this approval only ensures that the technologies are safe in terms of immediate harm. Therapeutic Goods Administration approval does not mean that the technologies can detect breast cancer or should be used as screening tools. Screening with mammography Screening is an organised program in which well people are invited to be tested for signs of a disease in its early stages, or before it develops symptoms. Screening does not diagnose the disease but identifies people who need to undergo further tests to determine whether the disease is present. Regular screening mammograms have been proven to reduce the number of breast cancer deaths. BreastScreen WA offers women free mammograms (breast x-rays) to screen women for breast cancer. Women aged 50-69 are invited to attend, and women aged 40-49 and 70+ years are also eligible to attend. BreastScreen WA is rigorously audited to ensure the safety and quality of its service. The operators offering unproven breast imaging commercially are not subject to any audit or quality control measures to ensure they deliver their services in a safe manner. Computer Tomography Laser Mammography (CTLM) Computed tomography laser mammography (CTLM) sends near infrared light into breast tissue. Near infrared light is absorbed by haemoglobins (proteins) in the blood, which act as a contrast medium. The CTLM device is claimed to detect increased blood vessel formation in tissue, which is a feature of tumours. CTLM is a new technology that does not appear to have been clinically evaluated as a stand alone test for breast cancer detection. The existing evidence reveals major limitations with the low resolution of CTLM images, and indicates CTLM requires considerably further development and evaluation. There do not appear to be any clinics offering CTLM technology yet in Western Australia, however the Australasian distributor for CTLM is based in Perth. Summary It is vital that women understand that the unproven breast imaging technologies featured in this fact sheet are not proven to effectively detect or screen for breast cancer. Research does not confirm that any of the technologies are valid alternatives to mammographic screening, and clinical decisions cannot be based on the results of these unproven imaging tests. Women with a lump detected using an unproven breast imaging device will still require assessment using conventional, validated methods, such as mammography or breast ultrasound, for a definitive diagnosis. Of the range of techniques in use for the detection of breast cancer, mammography is currently the only examination that is supported by objective and randomised clinical trials for screening and diagnosis. To book your mammogram appointment with BreastScreen WA phone 13 20 50 (cost of a local call). For more information about the BreastScreen WA program visit: www.breastscreen.health.wa.gov.au All women should be aware of the look and feel of their breasts. If they notice any change in their breasts, such as a lump, redness, pain, puckering of the skin or nipple discharge, they should contact their doctor promptly to arrange furt
Odd how the parent company still says no distribution, and Shimadzu Au still has yet to make their own announcement, which is actually from them.
You realize Shamadzu Au covers Australia, New Zealand, and the South Pacific, and IMDSs regulatory status was cancelled in Australia and not submitted in New Zealand?
And look at Shimadzu Australia's main page here, http://www.shimadzu.com.au/ . See all that company news, where is the IMDS news?
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