US-based Koning Health, a global leader in advanced breast imaging technology, has announced that the Koning Breast CT System has been successfully included in the Australian Register of Therapeutic Goods (ARTG), marking an important regulatory milestone for the company's expansion into the Australian market.
The Therapeutic Goods Administration (TGA) approved the inclusion of the Koning Breast CT System, CBCT 1000, under ARTG No. 531059. With the device now included in the ARTG, commercial supply in Australia may begin in accordance with applicable regulatory requirements and the conditions of the ARTG inclusion.
The Koning Breast CT System uses cone beam computed tomography to acquire true 3D images of the breast without compression. The system is designed to provide detailed volumetric breast imaging while creating a more comfortable experience for patients compared with traditional compression-based breast imaging.
The Australian regulatory approval builds on Koning Health's continued international growth and expanding presence across global markets. It also clears the way for the company to begin supporting its first Australian customers, including Brisbane Radiology, the first provider in the country to purchase the Koning Breast CT System.
