General Electric Confirms FDA (510k) Approval of SenoBright

General Electric Confirms FDA (510k) Approval of SenoBrightGeneral Electric (NYSE:GE) has announced that their health care unit, GE Healthcare, has received FDA (510k) approval for SenoBright, a technology which aids physicians in breast cancer diagnosis.

The full name of the technology is “SenoBright Contrast Enhanced Spectral Mammography” (or, CESM) and “produces contract-enhanced images of the breast using a legally approved x-ray contrast agent and a dual energy acquisition technique,” according to GE.  GE says that it has already been used in mammography centers in France, Spain, Italy, Belgium, Germany, Austria, and Japan.

GE seems to believe that one of the most compelling things about the technology is that it creatures two separate but nearly simultaneous exposures which allow illumination and highlighting of iodinated contrast.

Dr. Clarisse Dromain at the Gustave Roussy Cancer Institute in France, said, “CESM presents two images per mammographic view, one that looks like standard mammography and a second image that showed the contrast enhanced areas that can help localize a lesion. As the images are familiar, it can therefore be easily reviewed by surgeons and oncologists. Moreover in terms of workflow, a CESM exam takes from 5 to 10 minutes.”

GE released the following statement regarding the technology, “Worldwide, more than 1.2 million people annually are diagnosed with breast cancer. Since 1965, GE Healthcare has made significant progress in providing solutions for breast cancer detection and diagnosis that really bring a change to people’s lives. Today through ‘healthymagination’, we continuously develop innovations to reduce costs, increase access and improve quality and efficiency of healthcare delivery around the globe,” said Anne LeGrand, GE Healthcare’s vice president and general manager of the company’s global X-ray business.

Shares of GE spent most of today in a sideways trend before closing at $16.22 per share just under where it opened earlier this morning at $16.23.  Notable is that GE broke above resistance of August 17th’s price level of $16.54 yesterday.

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