Koning Health Announces Australian Regulatory Approval for Koning Breast CT System

Koning Breast CT System added to the Australian Register of Therapeutic Goods, enabling commercial supply in Australia

NORCROSS, Ga., Sept. 19, 2026 /PRNewswire/ -- Koning Health, a global leader in advanced breast imaging technology, today 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 on September 8, 2026. 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.

"This is an important milestone for Koning and for our continued global expansion," said David Georges, President of Koning. "We are grateful to everyone who worked tirelessly to bring this technology to Australia, and we look forward to supporting providers as they introduce a new approach to dedicated breast imaging for their patients."

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.

Brisbane Radiology's early commitment to the technology reflects the growing interest among imaging providers in advancing the breast imaging experience and expanding access to innovative technologies.

"We are incredibly proud to be the first in Australia to bring this technology to our patients," said Jacqui Milne, Clinical Director at Brisbane Radiology. "This approval is an exciting milestone, not only for our team, but for the future of breast imaging in Australia. We are looking forward to helping introduce this technology and seeing the opportunities it may create for patients and providers across the country."

"We are thrilled to reach this point," said Georges. "Australia represents an important market for breast imaging innovation, and Brisbane Radiology's early commitment demonstrates the kind of forward-thinking leadership that helps bring new technologies into clinical practice. We believe this is only the beginning of a much broader opportunity across the country."

Koning Health will continue working with its Australian partners to support commercialization, provider education, installation, and clinical adoption while ensuring compliance with all applicable TGA requirements.

About Koning HealthKoning Health is a global health technology company dedicated to advancing breast imaging through its patented Koning Vera Breast CT system. The Koning Vera Breast CT is designed to provide true 3D images of the breast for diagnostic evaluation. Koning's mission is to enhance the way clinicians visualize and assess breast tissue using advanced computed tomography technology while providing a more comfortable breast imaging experience to patients. For more information, please visit www.koninghealth.com or contact info@koningcorporation.com.