Imaging Diagnostic Systems (Imaging Diagnostic), engaged in the field of laser optical breast imaging, has received approval from the Australian Government Department of Health and Ageing Therapeutic Goods Administration (TGA) to market its CT Laser Mammography (CTLM) system in the country.
The company said that the approval has been obtained through the efforts of Jainsons, the official distributor of the CTLM system in Australia. Jainsons will introduce the system to the Australian market through commercial and clinical exhibitions, advertising, and the development of clinical studies and partnerships.
Deborah Brien, senior vice president of Imaging Diagnostic, said: “Gaining approval in Australia is an important step for us. It enables us to reach the Australian market and to perhaps influence related markets. We are very pleased with the work that our distributor has been doing in this market and anticipate many new developments from this approval.”
Mukesh Jain, chairman and CEO of Jainsons, said: “Australia TGA approval will open the well-informed and educated Australian market to the CTLM system. 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.”
The Therapeutic Goods Administration (TGA) approves the inclusion of all medical devices on the Australian Register of Therapeutic Goods (ARTG) before devices are being sold in Australia.