The End of Compression: Koning's 3D Breast CT Reshapes Australian Medtech

NORCROSS, Ga. – September 18, 2026 – For decades, the standard protocol for breast cancer screening has been defined by a physical reality: 10 to 20 kilograms of mechanical force. While conventional 2D mammography has undeniably saved millions of lives, the pain and discomfort associated with tissue compression remain a significant barrier to routine screening compliance. Now, a fundamental shift in diagnostic imaging is taking root in the Asia-Pacific region, challenging the long-standing technological status quo.

Koning Health, a medical imaging manufacturer based in Georgia, has officially secured regulatory clearance from the Australian Therapeutic Goods Administration (TGA) for its Cone Beam Breast CT System (CBCT 1000). Added to the Australian Register of Therapeutic Goods (ARTG No. 531059) earlier this month, the approval authorizes commercial supply across the country and marks a pivotal moment in the consumerization of women’s healthcare.

With Brisbane Radiology already announced as the first domestic purchaser, the rollout of this technology offers a critical case study in how medical device companies are leveraging patient-centric design to disrupt established clinical pathways.

The Technological Shift: True 3D Without the Squeeze

To understand the strategic value of the newly approved system, one must look at the limitations of current market leaders. Conventional full-field digital mammography (FFDM) collapses three-dimensional breast anatomy into a flat, two-dimensional image. In patients with dense breast tissue—which accounts for over 40% of the screening population—overlapping fibroglandular parenchyma can mask non-calcified cancers. This "masking effect" can drop diagnostic sensitivity from roughly 85% in fatty breasts to as low as 45% in highly dense tissue.

While digital breast tomosynthesis (DBT) improved upon this by acquiring images over a limited arc to create a "pseudo-3D" view, it still requires mechanical compression and lacks true depth resolution.

The Koning Vera system bypasses these mechanical and physical limitations entirely. The patient lies prone on an ergonomically padded table, allowing the breast to hang naturally through an aperture. Beneath the table, a cone-beam X-ray source and a flat-panel digital detector complete a full 360-degree rotation in just seven to ten seconds. The result is a true isotropic 3D volumetric image, boasting voxel dimensions as fine as 0.155 millimeters, completely eliminating tissue superimposition.

Crucially, dosimetric evaluations confirm that this true 3D acquisition delivers a radiation dose comparable to a standard diagnostic mammographic workup—roughly 2 to 3 milligrays per breast.

"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."

Solving the Compliance Crisis in Breast Screening

The strategic implications of compression-free imaging extend far beyond image clarity; they strike at the heart of preventative healthcare economics. Industry analysts and healthcare advocates note that up to 40% of eligible women delay or skip routine mammograms, frequently citing the anxiety and severe physical discomfort associated with the procedure. For women with breast implants, the fear of implant rupture under mechanical force adds another layer of reluctance.

By removing the physical dread of the examination, medical imaging providers can fundamentally alter patient behavior. In an era where healthcare is increasingly consumer-driven, clinics that offer a pain-free, highly accurate alternative possess a distinct competitive advantage. Patient acquisition and retention in private radiology are heavily influenced by the clinical experience, making non-compressive technologies a powerful differentiator.

Brisbane Radiology’s early adoption of the technology highlights this shifting market dynamic. The clinic is positioning itself at the forefront of patient-centric care, recognizing that technological investments must align with consumer demands.

"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."

The Economic Reality: Navigating the Reimbursement Chasm

Despite the clinical and experiential advantages, the commercial rollout of cone-beam breast CT in Australia faces substantial economic hurdles. Regulatory clearance allows a device to be sold, but reimbursement dictates whether it will be widely adopted.

Currently, dedicated cone-beam breast CT does not have a specific item number on the Australian Medicare Benefits Schedule (MBS). Consequently, early access to the technology operates outside the publicly funded BreastScreen Australia program. Patients referred for a scan at pioneering clinics like Brisbane Radiology must pay out-of-pocket, with industry benchmarks suggesting fees ranging between $250 and $450 AUD per examination.

This creates a strategic bottleneck. For private radiology practices, integrating the new system requires a hefty capital expenditure—specialized breast CT units typically cost between $750,000 and $1.2 million AUD. Furthermore, the massive datasets generated by true 3D volumetric imaging require significant IT infrastructure upgrades, including 32-megapixel diagnostic monitors and increased radiologist reading times.

To achieve true market penetration, the manufacturer and its local sponsors must navigate the complex Medical Services Advisory Committee (MSAC) evaluation process. Securing public funding will require comprehensive health-economic data and local randomized controlled trials demonstrating that the downstream savings—such as fewer false-positive biopsies and earlier detection of masked tumors—outweigh the initial capital and procedural costs.

Until that reimbursement bridge is built, the market risks developing a two-tiered system: one where cutting-edge, pain-free diagnostic imaging is reserved for those who can afford the private-pay premium, while the broader population relies on standard compressive modalities.

A Strategic Beachhead in the Asia-Pacific

Australia has long been viewed by global medtech firms as a premium testbed. The nation boasts a highly regulated healthcare system, world-class clinical leadership, and a robust private radiology sector willing to invest in premium diagnostic tools. By securing a foothold here, the Georgia-based manufacturer is not merely opening a new revenue stream; it is establishing a high-credibility reference market to support broader expansion across the Asia-Pacific region.

The initial deployment in Queensland will serve as a critical proving ground. Competitors and investors alike will be closely monitoring machine utilization rates, patient feedback metrics, and the workflow adaptations required by radiologists reading isotropic 3D scans.

"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," Georges noted, emphasizing the broader strategic vision. "We believe this is only the beginning of a much broader opportunity across the country."

As the medical technology sector continues to pivot toward solutions that marry advanced clinical efficacy with improved patient comfort, the introduction of compression-free breast CT serves as a powerful indicator of where the industry is heading. The companies that will dominate the next decade of diagnostic imaging are those that recognize a simple truth: the best technology is not just the one that sees the clearest, but the one that patients are actually willing to use.