The system utilizes cone beam computed tomography to generate high-resolution 3D images of breast tissue. Unlike traditional mammography, the technology eliminates the need for breast compression, a design intended to improve patient comfort during diagnostic procedures. This regulatory green light facilitates the immediate launch of the device, with Brisbane Radiology set to serve as the inaugural Australian provider to implement the system.
Koning Health Secures Australian Approval for Breast CT Technology
The Therapeutic Goods Administration has granted regulatory clearance for the Koning Breast CT System, officially clearing the device for commercial use in Australia. Registered under ARTG No. 531059 as of September 8, the approval marks a strategic expansion for the Norcross-based company into the Asia-Pacific diagnostic market.
David Georges, President of Koning Health, stated that the move represents a significant step in the company’s international growth strategy. Clinical Director at Brisbane Radiology, Jacqui Milne, noted that the facility plans to leverage the technology to advance local imaging standards. The company will now shift focus toward provider education and site installation to support clinical adoption across the country.
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