Koning Health Achieves Australian Regulatory Approval for Breast CT System
Koning Health, a premier player in the realm of breast imaging technology, has made a significant stride by securing regulatory approval for its Koning Breast CT System in Australia. This achievement marks an essential milestone that allows the company to broaden its reach in the healthcare sector, specifically in breast imaging, which is crucial for early detection and diagnosis.
On September 8, 2026, the Therapeutic Goods Administration (TGA) approved the inclusion of the Koning Breast CT System, registered under ARTG No. 531059, into the Australian Register of Therapeutic Goods (ARTG). With this inclusion, commercial supply of the system in Australia is slated to commence, following all necessary regulatory protocols.
David Georges, President of Koning Health, expressed gratitude to everyone involved in bringing this pioneering technology to Australia. He stated, "This is an important milestone for Koning and for our continued global expansion. We look forward to supporting providers as they introduce a new approach to dedicated breast imaging for their patients."
Advanced Imaging without Compression
The Koning Breast CT System operates using cone beam computed tomography technology, allowing it to create true three-dimensional images of the breast anatomy without any need for compression. This is particularly beneficial as traditional breast imaging methods often require patients to endure uncomfortable compression, which may lead to anxiety and increased discomfort.
By providing detailed volumetric breast images, the Koning Breast CT System facilitates more accurate diagnoses while ensuring a comfortable experience for patients. This technological edge positions Koning Health as a leader in the breast imaging market, contributing to better patient outcomes through enhanced imaging quality.
Brisbane Radiology: A Pioneer in Adoption
What’s more exciting is that Brisbane Radiology has become the first provider in Australia to acquire the Koning Breast CT System. Jacqui Milne, Clinical Director at Brisbane Radiology, commented on the significance of this approval, stating, "We are incredibly proud to be the first in Australia to bring this technology to our patients. This approval is an exciting milestone, not only for our team but for the future of breast imaging in Australia."
Brisbane Radiology's commitment to adopting the technology reflects the growing interest in improving breast imaging techniques, making advanced technologies more accessible to healthcare providers and patients alike.
The Future of Breast Imaging in Australia
With this approval, Koning Health is set to support its Australian partners through commercialization efforts, provider education, installation, and clinical adoption, ensuring that all TGA requirements are met. The company envisions this move as the beginning of a much broader opportunity within Australia’s healthcare landscape, providing innovative imaging solutions that benefit both patients and providers.
As breast cancer remains one of the most common cancers affecting women globally, advancements like the Koning Breast CT System hold the potential to make a significant impact in early detection and overall patient care. In conclusion, Koning Health’s regulatory approval in Australia symbolizes a progressive step forward in technology, aiming to enhance the quality of care in breast imaging significantly.
For more information about Koning Health and its innovative solutions in breast imaging, visit
www.koninghealth.com.