Navigation Links
Medicsight PLC Receives Additional Information Request for FDA 510(k) Clearance
Date:1/20/2009

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 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.


'/>"/>
SOURCE MGT Capital Investments, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Medicsight PLC Presents New Data at RSNA 2008 Further Supporting Relevance of Computer-Aided Detection (CAD) and Image Analysis Software in Early Colon Cancer Screening and Diagnosis
2. Medicsight Announces New Global Marketing Partnership with Ziosoft Unveiled at RSNA 2008
3. Medicsight ColonCAD Technology Successfully Identified Cancer in 100% of Patients Included in Data Presented at ESGAR 2008
4. Medicsight Announces Appointment of NM Rothschild & Sons Limited as Corporate Adviser
5. MGT Capital Investments, Inc. is Delighted with the Announcement of Medicsights Commercial Agreement with Toshiba PACS Division
6. Abbott Receives FDA CLIA Waiver for Use of Five Additional Cartridges on the i-STAT Handheld Blood Analyzer
7. CSL Behring Receives FDA Approval of RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
8. Allscripts Receives 2008 CCHIT Certification
9. Nu Skin Enterprises Receives Broader Direct Selling Authorization in China
10. Avalon Laboratories receives FDA and European clearances to market 3 catheter devices
11. Avalon Laboratories receives FDA and European clearances to market three catheter devices
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/6/2016)... ... December 06, 2016 , ... The Behavioral Health ... Distinction, recognizing the organization as a top behavioral service provider in the country. ... clinical quality, staff satisfaction and qualifications, and consumer satisfaction. These areas are measured ...
(Date:12/6/2016)... ... December 06, 2016 , ... Experimentation ... research and development, largely due to its potential for revolutionizing human disease treatment. ... and human induced pluripotent stem cells (hiPSCs). , Both platforms have distinct ...
(Date:12/6/2016)... ... December 06, 2016 , ... METTLER TOLEDO has ... knowledge resources, including white papers, guides, handbooks, case studies, magazines, webinars, videos, catalogs, ... more than 9,000 documents, webinars and videos available online, visit the METTLER ...
(Date:12/6/2016)... ... ... 'Tis the season for family, festivity, food and fun! Temptation abounds, and ... eating healthy, staying active, and taking medication and doing daily foot health checks (a ... "Shopping trips, parties and family gatherings can take their toll on our feet during ...
(Date:12/6/2016)... (PRWEB) , ... December 06, 2016 , ... ... the availability of the newly updated International Audit Protocol Consortium (IAPC) EHS audit ... EHS audit protocols to understand the scope of their EHS regulatory obligations and ...
Breaking Medicine News(10 mins):
(Date:12/5/2016)... , Nov. 29, 2016 Several leading Alzheimer,s ... Accera, Inc. at 11 a.m. EST on ... Conference on Clinical Trials for Alzheimer,s Disease (CTAD). The ... in Alzheimer,s disease and therapeutic targets that address deficient ... "Following the recent failure of another therapy targeting the ...
(Date:12/5/2016)... BOCA RATON, Fla. , Dec. 5, ... Commercialization of Public Research (the Florida Institute) ... agreement SegAna, LLC, an Orlando ... Central Florida. The Florida Institute supports new company ... funding gaps for companies spinning out of Florida-based universities ...
(Date:12/5/2016)... According to a new market research report "Cartilage Repair/ Cartilage ... Scaffolds, Cell-free composites), Application (Hyaline Cartilage, Fibrocartilage), by Region - Forecast ... USD 779.8 Million by 2021 from USD 414.6 Million in 2016, ... 2016 to 2021. Continue Reading ... ...
Breaking Medicine Technology: