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Article: Medicsight PLC Receives Additional Information Request for FDA 510(k) Clearance.
- Article from:
- PR Newswire
- Article date:
- January 20, 2009
CopyrightCOPYRIGHT 2009 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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NEW YORK, Jan. 20 /PRNewswire-FirstCall/ -- Medicsight PLC, a subsidiary of MGT Capital Investments, Inc. (NYSE-A: MGT), and an industry leader in the development of Computer-Aided Detection (CAD) and image analysis software, which assists radiologists in the early detection of disease, announces that it has received a request for Additional Information (AI) letter from the U.S. Food and Drug Administration (FDA). This request is in regard to the 510(k) pre-market notification for the ColonCAD API 3.1 product. The FDA has requested clarification of the intended use of the product. Medicsight is collating the information required, will continue discussions with the FDA ...
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