Medicsight PLC Receives Additional Information Request for FDA 510(k) Clearance
20 Janvier 2009 - 2:00PM
PR Newswire (US)
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 and will provide a response to
the agency in due course. About MGT Capital Investments, Inc. MGT
Capital Investments, Inc. is a technology holding company that
focuses on investments in the global healthcare information
technology market. The Company has two subsidiaries, Medicsight PLC
and Medicexchange PLC. Medicsight PLC (AIM: MDST) is a
UK-headquartered, research driven, leading developer of
computer-aided detection (CAD) and image analysis software for the
medical imaging market. The CAD software automatically highlights
suspicious areas on computerized tomography (CT) scans of the colon
and lung, helping radiologists to identify, measure and analyze
potential disease and early indicators of disease. Medicsight's CAD
software has been validated using one of the world's largest and
most population diverse databases of verified patient CT scan data.
Medicsight's ColonCAD(TM) and LungCAD(TM) software products are
seamlessly integrated with the advanced 3D visualization
workstations of several industry-leading imaging equipment
partners. Medicexchange PLC provides medical imaging professionals
with a global web portal containing an online sales, jobs and
information channel for diagnostic, treatment and surgery planning
solutions. This combined with a variety of relevant clinical
papers, training materials and content gives these professionals
access to information and products that they otherwise would have
difficulty accessing. Additional information can be found at
http://www.mgtci.com/. All forward-looking statements are made
pursuant to the 'safe harbor' provisions of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements are based
on current management expectations that involve risks and
uncertainties that may result in such expectations not being
realized. Potential risks and uncertainties include, but are not
limited to, the risks described in company filings with the
Securities and Exchange Commission. DATASOURCE: MGT Capital
Investments, Inc. CONTACT: Investor & Media enquiries: Todd
Fromer, +1-212-896-1215, ; or Garth Russell, +1-212-896-1250, ,
both of KCSA Strategic Communications for MGT Capital Investments,
Inc. Web Site: http://www.mgtci.com/
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