NeuroLogica Receives CE Safety Mark Certification for the NL3000 CereTom(TM) CT.Approval Clears the Way for First European Luminary Site Installation in Sweden DANVERS, Mass. -- NeuroLogica Corporation today announced it has received the CE product safety certification mark A certification mark on a commercial product indicates five things:
n. See CAT scanner. , into medical facilities throughout the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community as well as other countries that accept the CE Mark. NeuroLogica will install the CereTom at its first European luminary site at the University Hospital, Linkoping, Sweden. "This is a major accomplishment for our company, and it will allow us to further our mission, of bringing greater access globally to quality, mobile neuro-imaging," Eric Bailey, President and Co-founder of NeuroLogica Corporation, stated. "In addition to leading medical centers in the US using the CereTom, including The Massachusetts General Hospital Massachusetts General Hospital Health care The major teaching hospital for Harvard Medical School, widely regarded as one of the best health care centers in the world and UCLA Medical Center UCLA Medical Center is a hospital located on the campus of the University of California, Los Angeles in Los Angeles, California. It is rated as one of the top three hospitals in the United States and is the top hospital on the West Coast according to US News & World Report. , hospitals in Europe Lists of hospitals for each country in Europe.
For the CE Mark, the CereTom was evaluated against the applicable medical device safety standards: EN60601-1, EN60601-1-1, EN60601-1-2, EN60601-1-4, EN60601-2-32, EN60601-2-44, manufacturing, documentation and systems compliance reviews. Vertec Scientific Ltd. will serve as both NeuroLogica's EU representative and their official distribution partner for the CereTom throughout the UK and Europe. NeuroLogica will next apply for the appropriate certification required for global distribution including Japan, China, Hong Kong, Korea and India. About NeuroLogica: Based in Danvers, Mass., NeuroLogica Corporation, a neuro-science based imaging company, develops, manufactures and markets advanced medical imaging equipment. The company's mission is to bring access to high quality neuro-imaging to all people regardless of where they live. Combining superior imaging quality and easy access enables physicians to make more informed treatment decisions that save and improve patient lives, specifically in neuro-related conditions. |
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