Elekta Recieves U.S. Regulatory Approval for Treatment Planning on Leksell Gamma Knife(R) Perfexion(TM).STOCKHOLM, Sweden -- On July 5, the U.S. Federal Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) announced a 510(k) pre-market clearance for Leksell GammaPlan(R) PFX PFX Personal Information Exchange PFX Powerflex (database file extension) PFX Purple Fluid Exchange (band) PFX Generic Police Term for Multi-Channel Packset Radio (TM), the treatment planning system developed for Leksell Gamma Knife Gamma Knife A trademark for a radiologic nonsurgical device used in stereotactic radiosurgery. Gamma knife A surgical tool that focuses beams of radiation at the head, which converge in the brain to form a lesion. (R) Perfexion(TM). By the ongoing market introduction of Leksell Gamma Knife Perfexion, Elekta (STO:EKTA) expands the Leksell Gamma Knife(R) product line with a completely new system that takes stereotactic radiosurgery to the next level and provides a radiosurgical platform for further refinement and expansion of procedures in the brain, cervical spine and head & neck regions. Leksell Gamma Knife Perfexion is pending 510(k) clearance from the FDA. "Leksell GammaPlan PFX is a vital part of Elekta's brand new platform for stereotactic radiosurgery, providing unmatched ease-of-use and reaping the benefits of the highly innovative design of Leksell Gamma Knife Perfexion", says Vincent Denot, Elekta's Product Manager for Leksell GammaPlan. "This 510(k) pre-market clearance from FDA is an important milestone in the Perfexion project and yet another such event that is occurring exactly according to plan", Denot concludes. ****** About Elekta Elekta is an international medical-technology Group, providing meaningful clinical solutions, comprehensive information systems and services for improved cancer care and management of brain disorders. All of Elekta's solutions employ non-invasive or minimally invasive techniques and are therefore clinically effective, gentle on the patient and cost-effective. Clinical solutions include among others Leksell Gamma Knife(R) for non-invasive treatment of brain disorders and Elekta Synergy(R) for image guided radiation therapy (IGRT IGRT Image Guided Radiation Therapy ). Following the acquisition of IMPAC IMPAC International Merchant Purchase Authorization Card IMPAC Intersegmental Major Preparation Articulated Curriculum IMPAC Information for Management, Planning, Analysis, and Coordination (National Institutes of Health) Medical Systems Inc. in April 2005, the Elekta Group is the world's largest supplier of oncology software. Elekta's systems and solutions are used at over 3,000 hospitals around the world to treat cancer and manage clinical operations as well as to diagnose and treat brain disorders, including tumors, vascular malformations and functional disorders. With approx. 1850 employees, Elekta's corporate headquarter head·quar·ter v. head·quar·tered, head·quar·ter·ing, head·quar·ters Usage Problem v.tr. To provide with headquarters: is located in Stockholm, Sweden and the company is listed on the Stockholm Stock Exchange The Stockholm Stock Exchange (Swedish: Stockholmsbörsen) is a stock exchange located in Stockholm, Sweden. Founded in 1863 [1] it is the primary securities exchange of the Nordic Countries. under the ticker EKTAb. For more information about Elekta, please visit www.elekta.com. This information was brought to you by Waymaker http://www.waymaker.net |
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