Norcross, Ga. – September 20, 2026 -- Koning Health's Breast CT System, the CBCT 1000, has been added to the Australian Register of Therapeutic Goods (ARTG No. 531059), clearing the device for commercial supply in Australia.
TGA approves device inclusion on September 8, 2026
The Therapeutic Goods Administration granted the ARTG listing on September 8, 2026, allowing Koning Health to begin commercial supply in Australia subject to regulatory conditions tied to the inclusion.
Brisbane Radiology becomes first Australian buyer of the system
Brisbane Radiology has committed to purchasing the Koning Breast CT System, making it the first provider in the country to adopt the technology. Clinical Director Jacqui Milne said the approval marks a milestone for breast imaging in Australia and expects it to create new opportunities for patients and providers nationwide.
System uses cone beam CT to image breast without compression
The Koning Breast CT System applies cone beam computed tomography to generate true 3D volumetric images of the breast without the compression required by conventional imaging methods, aiming to improve patient comfort during diagnostic evaluation.
Koning targets broader Australian rollout following initial approval
David Georges, President of Koning, called the ARTG inclusion an important milestone for the company's global expansion and said Brisbane Radiology's early commitment reflects forward-thinking leadership in adopting new imaging technologies. Koning Health will continue working with Australian partners on commercialization, provider education, installation and clinical adoption while maintaining compliance with TGA requirements.