Medicsight PLC Receives Additional Information Request for FDA 510(k) Clearance
26 Enero 2010 - 3:15PM
PR Newswire (US)
NEW YORK, Jan. 26 /PRNewswire-FirstCall/ -- Medicsight PLC, a
subsidiary of MGT Capital Investments, Inc. (NYSE Amex: 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 on January 5, 2010 it
received a further request for Additional Information (AI) letter
from the US Food and Drug Administration (FDA) relating to the
Company's currently pending 510(k) pre-market notification for the
ColonCAD API 3.1 product. The FDA previously issued an AI letter to
the Company in December, 2008 requesting clarification of the
intended use of the product, to which the Company responded. In the
most recent AI letter the FDA has requested further technical
details regarding the clinical trials and data analyses undertaken
to support clearance of the product. FDA 510(k) submissions for
Class 2 devices such as the current ColonCAD API 3.1 submission are
necessarily complex and require the sponsor company to provide a
great deal of information relating to the design, manufacture and
validation of the product. It is not unusual for a second AI
request to be received by a company in order for the FDA to gain
all the information they require in order to assess a device.
However, the FDA's 510(k) process is typically restricted to two AI
letters. Allan Rowley, CEO of Medicsight, said: "We are working
expediently with our clinical and statistical advisors and the FDA
to prepare the requested information and expect to respond fully to
the FDA before the deadline of June 21, 2010." 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.; Medicsight PLC CONTACT:
Allan Rowley, Chief Financial Officer, MGT Capital Investments,
Inc., P: 011-44-20-7605-1151 Web Site: http://www.mgtci.com/
Copyright