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Sepracor's STEDESA™ (Eslicarbazepine Acetate) New Drug Application Formally Accepted For Review By The FDA
Sepracor Inc. (Nasdaq: SEPR) today announced that it has been notified by the U.S. Food and Drug Administration (FDA) that the New Drug Application (NDA) for STEDESA™ (eslicarbazepine acetate) has been accepted for filing and is now under formal review. As previously announced, the NDA for STEDESA was submitted to the FDA on March 31, 2009 for adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. The acceptance of the filing means that the FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive review.
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Improvements In Sexual And Reproductive Health Of Teens And Young Adults Slowing
After a period of improvement, trends in the sexual and reproductive health of U.S. teens and young adults have flattened, or in some instances may be worsening, according to a new report from the Centers for Disease Control and Prevention.
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Radiotherapy Link To Breast Cancer And Heart Disease Found
Scientists have found a way to identify breast cancer patients at risk of heart disease after radiotherapy, according to a report published yesterday.
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Varian Medical Systems Acquires Assets Of IKOEmed And IKOEtech; Acquisition To Add Software For Accelerating Radiotherapy Treatment Planning

Varian Medical Systems, Inc., (NYSE: VAR) announced it has acquired the assets of Houston-based IKOEmed and IKOEtech, privately-owned suppliers of software used in the planning of radiotherapy and radiosurgery treatments. The acquisition enables Varian to offer hospitals and clinics an additional software tool to automate and accelerate the most time-consuming portion of the treatment planning process. Varian is paying approximately $2.2 million plus an additional amount based on achievement of specified milestones to acquire the IKOE assets. The software is designed to achieve greater than 50 percent reduction in the contouring portion of the radiotherapy treatment planning process, which typically takes anywhere from 30 minutes to 4 hours. It automates the contouring process by matching patient images with pre-contoured images from an expert database created by renowned radiation oncologists. This eliminates the need for clinicians to manually outline between 10 and 20 organs in each of anywhere from 100 to 200 images of a patient"s disease site. "This is another important step in our ongoing initiative to make cancer treatments better, faster, easier, and more cost effective," said Tim Guertin, president and CEO of Varian Medical Systems. "This new tool should save a lot of time in planning for complex cases, particularly in cancers of the head and neck and lymph systems." The IKOE software, which has FDA 510(k) clearance, complements Varian"s existing segmentation tools currently used to automate planning for prostate, breast, and lung treatments. Varian will sell the software initially in the U.S. as a standalone product that will work with most radiotherapy treatment planning software products in the industry. The company plans to integrate it with its global market leading Eclipse™ treatment planning software for radiotherapy, radiosurgery, and brachytherapy. Varian anticipates the acquisition be neutral to earnings for the company in the current fiscal year and accretive thereafter. "We expect that our worldwide sales, service, and support network will contribute to faster and deeper market penetration for these software products," Guertin said. The IKOE software is now installed in about 20 sites, primarily in the U.S. Four IKOE employees and consultants are being offered jobs with Varian to support the product at Varian facilities in the U.S. Varian Medical Systems


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