Koning Health has received regulatory approval from Australia’s Therapeutic Goods Administration (TGA) for its Koning Breast CT [computed tomography] System.
Listed under ARTG No. 531059, the platform is included in the Australian Register of Therapeutic Goods (ARTG). This enables the company to initiate commercial distribution in the country in line with local requirements.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The inclusion allows Koning Health to supply its CBCT 1000 device to healthcare providers in Australia.
The system uses cone-beam CT to produce 3D images of the breast without compression, aiming to make the scan more comfortable than traditional imaging methods.
The Koning Breast CT System is designed to provide volumetric images to assist clinicians in evaluating breast tissue.
The approval supports the company’s ongoing international growth efforts and will allow Koning Health to serve its first customers in Australia. Brisbane Radiology is said to be the first provider in the country to have purchased the Koning Breast CT System.
Koning Health president David Georges said: “This is an important milestone for Koning and for our continued global expansion. 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.
“We are thrilled to reach this point. 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 intends to continue its work with partners in Australia, aiming to support commercial activities, provider education, installation, and clinical adoption in compliance with TGA requirements.
The company focuses on improving breast imaging and patient comfort through advanced computed tomography technology.
