Medical imaging systems developer Koning has received approval from the US Food and Drug Administration (FDA) for its Breast CT (KBCT) system and KBCT-guided biopsy bracket.
The company has developed KBCT to provide three-dimensional (3D) images for diagnostic imaging of the breast.
Koning president and founder Dr Ruola Ning said: "This FDA approval represents a major step forward for breast imaging and women’s health care.
"Breast cancer is a growing worldwide women’s health issue impacting hundreds of thousands of women. We are very proud to now be able to offer our technology to benefit women here in the US."
According to Koning, the 3D breast CT scanner has been designed to image the entire breast with a single scan without compression of the breast tissue.
It has the capacity to acquire hundreds of images in ten seconds, while biopsy bracket allows 3D targeting at comparable or lower radiation exposure compared to stereotactic guided biopsy.
The company already received CE mark approval for KBCT, and is available for sale in the European Union, as well as in Canada and Australia.
Development of KBCT was supported by NIH grant, SBIR Bridge Grant and Government Grant, noted Koning.