Canadian regulatory approval paves the way for dedicated 3D breast imaging without compression.

NORCROSS, Ga., Oct. 20, 2026 /PRNewswire/ -- Koning Health today announced that the Koning Vera Breast CT system received its Medical Device License (MDL) from Health Canada. This regulatory license paves the way for Canadian healthcare providers to adopt Koning's dedicated breast computed tomography (CT) technology, which delivers high-contrast, three-dimensional (3D) breast imaging without the need for breast compression.

For Koning, this Health Canada licensure advances a core strategic objective: providing clinicians and patients with access to a dedicated breast imaging modality engineered to optimize image quality without compromising the patient examination experience.

"Women want to know that advances in breast imaging will make a difference in their experience of care," said David Georges, President of Koning. "Our Vera Scan brings together detailed three-dimensional imaging and an examination that does not require breast compression. With Health Canada licensure, we can take the next steps toward bringing that technology to Canadian providers and their patients."

What is Koning Vera Breast CT?

Koning Vera Breast CT, also known as KBCT, is a dedicated breast imaging system that uses cone beam computed tomography to generate volumetric images of breast tissue. The technology allows clinicians to examine the breast from multiple angles without compressing it during image acquisition.

The system was developed to address two priorities in breast imaging: providing detailed anatomical information for clinical evaluation and changing the physical experience of the examination. Its compression-free design is a defining feature of Koning's approach.

What does Health Canada licensure mean for Canada?

The issuance of a Medical Device License (MDL) by Health Canada is a critical regulatory milestone that authorizes the commercial introduction of the Koning Vera Breast CT system into Canadian clinical settings. This licensure establishes the pathway for Koning to expand clinical access across the country. Patient scan availability will be determined by individual participating imaging centers and hospital systems based on their specific implementation timelines.

This authorization follows Koning's recent registration in Australia and further extends the company's global footprint in bringing dedicated, compression-free breast CT technology to international healthcare markets.

Canadian healthcare providers interested in Koning Vera Breast CT can contact Koning Health to discuss the technology and opportunities for implementation.

About Koning Health

Koning 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 [email protected].

SOURCE KONING CORPORATION

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