New compression-free 3D breast imaging technology receives Health Canada licence

Regulatory milestone could expand diagnostic imaging options for Canadian healthcare providers, although clinical availability will depend on adoption by hospitals and imaging centres.

A new approach to breast imaging could soon become available to Canadian patients following the announcement that Health Canada has licensed a dedicated three-dimensional breast CT system designed to capture detailed images without breast compression.

Koning Health announced October 20 that its Vera Breast CT system has received a Canadian medical device licence, allowing the company to begin introducing the technology to healthcare providers across the country.

The system uses cone-beam computed tomography to create three-dimensional images of breast tissue. Unlike conventional mammography, which requires the breast to be compressed between imaging plates, the technology captures images without compression.

The resulting volumetric images allow radiologists to examine breast tissue from multiple angles, potentially providing additional anatomical information during diagnostic evaluations.

A different approach to breast imaging

Traditional mammography remains an important tool for breast cancer screening in Canada. However, researchers and medical technology companies continue developing imaging methods that may improve diagnostic assessment and the patient experience.

The Koning system is designed to address both image visualization and examination comfort.

By eliminating compression, the technology offers a different examination experience for patients who find conventional breast imaging uncomfortable.

Its three-dimensional imaging capabilities may also provide clinicians with additional views of breast structures during diagnostic assessment.

The technology is intended for diagnostic breast imaging and should not be considered a replacement for established mammography screening programs. Its specific authorized uses in Canada will be governed by the conditions of its medical device licence.

Canadian adoption will determine patient access

Although the regulatory milestone permits the company to move forward with commercial introduction, it does not mean the technology is already available at Canadian hospitals.

Individual hospitals and diagnostic imaging centres will determine whether and when to introduce the system, taking into account equipment procurement, clinical requirements, staff training and operational considerations.

Koning has not announced specific Canadian hospital installations or patient appointment dates as part of the licensing announcement.

For healthcare providers, the development represents another potential option in the evolving field of breast diagnostic imaging.

As imaging technology advances, clinical evaluation will remain important in determining how new systems complement existing diagnostic pathways, improve patient experiences and contribute to effective care.

The Canadian authorization follows the company’s recent regulatory registration of its breast CT technology in Australia.

With October marking Breast Cancer Awareness Month, the announcement highlights continuing efforts to develop imaging technologies that support the assessment of breast health.

Source: Koning Health — October 20, 2026

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