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A three-dimensional breast CT approved by the US Food and Drug Administration

Release Time:2015.12.24  Source:Dingxin Capital
The first cone beam breast CT for use in the diagnosis of breast

In Rochester, New York, 2015 February 4, / PRNewswire / - as a leading developer of advanced medical imaging systems, Corning (Koning Corporation) announced today that the U. S. Food and Drug Administration (FDA) approved guide the Corning breast CT KBCT system and KBCT biopsy under the bracket system. This approval marks the KBCT has gone through and successfully completed the FDA of the medical device strict pre listing approval (PMA) process of all specifications and requirements, including a wide range of clinical research. KBCT aims to provide three-dimensional (3D) images for the diagnosis of breast.

Corning president and founder, cone beam CT technology pioneer and senior experts and cone beam breast CT technique sole inventor Ning if pull (Ruola Ning,), said: "the FDA this approval showed that in breast imaging and women health care has taken an important step. KBCT represents a revolutionary advance in the field of breast cancer diagnosis. Breast cancer is a growing global women's health problem, which affects hundreds of thousands of women in the United States. We are very pleased to be able to introduce this technology, so that the United States to benefit women."

KBCT is the world's first commercially oriented three-dimensional breast CT system, after special design, no need to squeeze the breast tissue, and dedicated to the whole breast of a one-time three-dimensional imaging. The system in 10 seconds to collect hundreds of images to generate a "real" three-dimensional image, the inspection process is convenient and fast, and provides excellent patient comfort. KBCT optional accessories include support of suspicious lesions were KBCT guided breast biopsy biopsy bracket and for restricting X-ray collimator in the region of interest. Compared to the stereotactic guided biopsy, the biopsy system can be performed with a comparable or lower amount of radiation for three-dimensional positioning and navigation.

The FDA consumer health information (consumer health information) September 2014 edition published the article "3D technology will change how doctors diagnose cancer (3D technologies Poised to change how doctors diagnose cancer)", the FDA said due to the FDA of a team of scientists are to carry out the supervision work, soon the true 3D image may help doctors find hidden tumors and better diagnosis of cancer. The article shows that, for patients, because they do not need to squeeze the breast, this (CT) examination process than the conventional molybdenum target X light breast examination is more comfortable. In addition, the radiation dose was lower than that of the entire chest CT examination because of the scanning of the breast only. This (CT) image is more realistic than the conventional mammography X, and the system is optimized to distinguish between the soft tissue of the breast and the cancerous tissue. These images are significantly different from that of the conventional X - ray mammography, which is the real three-dimensional image of the entire breast. Physicians can scroll up and down the left and right to get a unique view of the breast in an unprecedented way. It provides a great freedom for physicians to observe and evaluate the structure of the interior of the breast, as it does in the anatomy of the breast.

In Elizabeth Wende breast care (Rochester, NY) and the University of Rochester Medical Center at the University of Rochester Medical Center) (Rochester, NY) a total of more than 680 patients were KBCT scanning, here also includes cooperation provided by the University of Massachusetts Medical Center at the University of Massachusetts Medical Center) (Worcester, Massachusetts). Later in the College of South Carolina Medical (MUSC) (South Carolina School of Medicine) by the world renowned breast imaging expert Dr. Pisano Etta and chief scientist of the scale of the reading test. "Compared to two-dimensional imaging, we have seen very significant results in 3D KBCT and have no need to squeeze out the breast so that CT can provide a more comfortable and painless examination procedure for women," Dr. Pisano said. I think the 3D KBCT will likely play a major role in many applications of the breast."


Corning Corporation is an international medical imaging company, in New York and in Tianjin, China (Corning Tianjin Medical Equipment Co., Ltd.) equipped with the company, committed to the development and marketization of the "most advanced" cone beam CT system. KBCT's development was supported by the National Institutes of Health (NIH) funding (CA103236 1R44), Bridge Grant SBIR (CA 103236-05 2R44) and federal government grants (W81XWH-09-1-0441). KBCT has been approved for sale in Canada, Australia and the European Union (CE). Corning is expected to get Chinese the food and Drug Administration (CFDA) approved the China soon.
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