Cone Beam Breast CT Approved for Diagnostic Imaging of the Breast in the EU

(West Henrietta, NY, USA), a developer of medical imaging systems that combine the benefits of digital X-ray and CT, called CBCT, have obtained CE marking approval for their Koning breast CT (KBCT) system. This approval means that KBCT is in compliance with relevant European Union (EU) legislation and medical device regulations allowing it to be marketed and sold throughout the EU and other countries recognizing the CE Marking.

“This CE mark approval represents a major step for breast-imaging, and women’s healthcare, in general,” said Ruola Ning, PhD, Koning’s president and founder, an innovator and leading expert in cone beam CT technology. “KBCT is the latest advancement in true 3D [three-dimensional] breast-imaging technology and focuses on a growing worldwide women’s health issue--the early detection and diagnosis of breast cancer. Breast cancer affects hundreds of thousands of women and is one of the most common forms of cancer in North America, Europe, and China. We are very proud to be able to bring this revolutionary technology to benefit women throughout the world.”

The system acquires a set of images in 10 seconds generating “true” 3D images and multiplanar cross-sectional slices. Compared to current 2D diagnostic mammography with well-known limitations, KBCT virtually eliminates tissue overlap and superimposition of structures, which are frequently responsible for failure to diagnose breast cancer early, when it is most treatable, therefore saving lives, and reducing ever rising healthcare costs.

Koning is currently seeking US Food and Drug Administration (FDA) approval in the United States, State Food and Drug Administration (SFDA) approval in China, and Canada Medical Device License. Koning will first market KBCT systems in Europe. As these regulatory approvals are achieved, distribution will be expanded to the United States, China, Canada, and additional International markets.

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