Calypso(R) Medical Receives ISO Certification for the Calypso(R) 4D Localization System.SEATTLE -- Calypso Calypso, in Greek mythology Calypso (kəlĭp`sō), nymph, daughter of Atlas, in Homer's Odyssey. She lived on the island of Ogygia and there entertained Odysseus for seven years. Medical Technologies, Inc. announced that its Calypso[R] 4D Localization Customizing software and documentation for a particular country. It includes the translation of menus and messages into the native spoken language as well as changes in the user interface to accommodate different alphabets and culture. See internationalization and l10n. System and Beacon[R] electromagnetic transponder A receiver/transmitter on a communications satellite. It receives a microwave signal from earth (uplink), amplifies it and retransmits it back to earth at a different frequency (downlink). A satellite has several transponders. manufacturing process has been certified by the International Organization for Standardization International Organization for Standardization (ISO) Organization for determining standards in most technical and nontechnical fields. Founded in Geneva in 1947, its membership includes more than 100 countries. (ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. ). ISO 13485 sets standards ensuring a comprehensive management system is used for the design and manufacture of medical devices. The certification status by the ISO demonstrates Calypso Medical meets an international set of standards and guidelines that are becoming vital components of business transactions, global trade and regulatory requirements. The Calypso[R] 4D Localization System utilizes proprietary electromagnetic technology in conjunction with implanted Beacon[R] electromagnetic transponders in the prostate. The system is designed to enable doctors to accurately and objectively setup radiation therapy treatment and then measure and monitor organ motion during radiation therapy delivery for cancer patients. "Our quality system has been in place since we started production last year," said John Stevens John Stevens is the name of a number of prominent people:
Senior Director of Quality Systems and Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: The U.S. Food and 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. ) granted 510(k) clearance for the Calypso[R] 4D Localization System and Beacon[R] electromagnetic transponders for use in the prostate in July, 2006. Based in Switzerland, ISO is a global network that identifies what international standards are required by business, government and society. It then develops them in conjunction with the sectors that will put them to use and delivers them to be implemented worldwide. The Calypso[R] 4D Localization System product platform is designed to provide objective, accurate and continuous, real-time tumor location information during external beam radiation therapy without adding ionizing radiation i·on·i·zing radiation n. High-energy radiation capable of producing ionization in substances through which it passes. Ionizing radiation . Continuous knowledge of the tumor location is expected to provide greater confidence to clinicians and patients when they know that the radiation beam is always on target. Because the product platform does not require expertise in interpreting x-ray or ultrasound images, it greatly reduces the time to perform patient setup, a well-recognized bottleneck in the radiation department workflow. "This in yet another step in broadening potential markets, particularly globally," said Eric Meier, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Calypso Medical. "The certification reflects the countless hours of dedication by our team and associates and we are proud of this accomplishment." About Calypso[R] Medical Technologies, Inc. Calypso Medical Technologies, Inc. ("Calypso") is a Seattle, WA based privately held medical device company founded in 2000. The Company's proprietary tumor localization system utilizes miniaturized implanted devices (Beacon[R] electromagnetic transponders) to continuously, accurately, and objectively pinpoint the location of tumors for improved accuracy in radiation therapy. Calypso addresses two major issues in modern radiation oncology radiation oncology n. The branch of radiology that deals with the use of ionizing radiation to treat cancers. radiation oncology : errors in treatment set-up and tumor motion during treatment. In addition, the Calypso[R] 4D Localization System's non-ionizing electromagnetic guidance has the potential to improve work flow efficiency and treatment room utilization. The technology is designed for body-wide cancers commonly treated with radiation therapy, including prostate, breast, lung, head, neck and other radiation therapy target organs. In July 2006, Calypso received 510(k) clearance from the FDA to market the product for use in the prostate only and commercialization commenced Q4 2006. Calypso[R], Beacon[R] and GPS for the Body[R] are registered trademarks and Motion Matters[TM], Nothing Tracks Like the Beacon[TM], Calypso Within[TM], Beacon Within[TM], and On Target, On With |
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