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Breast screening devices

Related information

25 March 2011

Web statement

24 September 2010

Concerns have been expressed that a range of breast screening devices based on technologies other than mammography have not been appropriately assessed for their safety or accuracy. These include technologies such as thermography (thermal imaging) and electrical impedance tomography.

The Australian Horizon Scanning Program has been established to provide advance notice of significant new and emerging technologies to health departments in Australia and New Zealand, and to exchange information and evaluate the potential impact of emerging technologies on their respective health systems. The Australian Horizon Scanning Program is a collaborative Commonwealth and State initiative guided by the Health Policy Advisory Committee on Technology (HealthPACT).

In February 2009, the Australia and New Zealand Horizon Scanning Network published a study on New and emerging technologies for breast cancer detection. This study reviews international evidence on emerging technologies for breast cancer detection, including thermography. The study highlights that there is insufficient evidence to support the use of technologies other than mammography for the early detection of breast cancer. Electronic copies of the report can be obtained from Australia and New Zealand Horizon Scanning Network.

The Therapeutic Goods Administration's (TGA) role is to assess the safety, quality and performance of medical device products before they can be supplied in the Australian market place with an emphasis on the use of the medical device as intended by the manufacturer. The TGA requires evidence-based data to support an inclusion in the Australian Register of Therapeutic Goods (ARTG).

TGA has commenced investigations into the supply of breast-screening devices to ensure they comply with TGA requirements.

Information about mammography and thermography is available on: Cancer Screening.

Notifications under Section 41KA of the Therapeutic Goods Act 1989 - Public notification and recovery of medical devices

Last updated 25 March 2011

The following devices have been cancelled from the Australian Register for Therapeutic Goods (ARTG) and the sponsors have been required to notify users of the cancellations.

Sponsor: Intermedical Pty Ltd
Product: Bio-energy field mapping device application software; diagnostic system software; sensor and sensor/device ARTG Nos. 179484, 179489, 179490, 179491.
Gazette notice: Commonwealth of Australia Gazette No. GN11, 23 March 2011

Sponsor: Health Screening Technologies (thermography system) - Innovative Technologies and Research Pty Ltd
Product: Electrical impedance scanner ARTG number 152697.
Gazette notice: Commonwealth of Australia Gazette, No. GN2, 19 January 2011

Sponsor: Medical Monitoring Systems T/A Meditherm Pty Ltd
Product: Camera thermographic (MED2000, MED2000 PRO, MED2000 IRIS) ARTG number 143474
Gazette Notice: Commonwealth of Australia Gazette, No. GN1, 12 January 2011

Content last updated: Friday, 25 March 2011

Web page last updated: Friday, 1 November 2013

URL: http://www.tga.gov.au/safety/alerts-device-breast-screening-100924.htm