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:2/10/2016)... ... February 10, 2016 , ... United ... Nesbitt as the latest addition to its growing list of Partner Firms. ... the Southeast, from Orlando to Huntsville and in between. , Harnessing the experience ...
(Date:2/10/2016)... ... February 10, 2016 , ... Pediatric therapists are challenged ... Research shows that the Goal Attainment Scale (GAS) captures 20% more change in ... learn more about the Goal Attainment Scale, Education Resources Inc. is offering a ...
(Date:2/10/2016)... ... February 10, 2016 , ... IDEX Health & Science, ... stainless steel (PLS) columns combine the strength of traditional stainless steel with the ... biological samples while operating at ultra-high pressures of 20,000 psi. The higher operating ...
(Date:2/10/2016)... , ... February 10, 2016 , ... Anxiety of older ... the start of Medicare Part D a decade ago, according to The Senior ... older adults on how they are coping with rapidly rising costs. “The implications ...
(Date:2/10/2016)... ... February 09, 2016 , ... ... the cause of injury may be one of many possible sources: sports, car ... Continuing Education Course , Mastering Rehab Solutions for the Complexities of Concussions ...
Breaking Medicine News(10 mins):
(Date:2/10/2016)... Feb. 10, 2016  Silicon Biosystems Menarini Inc., ... that help uncover the biological complexities of disease ... a developer of innovative technologies for genomics research, ... aimed at enabling translational researchers to obtain high-quality ... hundred tumor and normal cells in an optimized ...
(Date:2/10/2016)... India , February 10, 2016 ... a new market research report "Pharmaceutical Packaging Equipment Market ... Wrapping, Labeling & Serialization), by Product Type (Tablet, Powder, ... 2020", published by MarketsandMarkets, studies the global market during the ... expected to grow at a CAGR of 6.9% during ...
(Date:2/10/2016)... Feb. 9, 2016 On Tuesday, ... (FDA) met with its Arthritis Advisory Committee ... of Johnson & Johnson,s Remicade and most ... in the U.S. The Biologics Prescribers Collaborative ... - Alliance for Patient Access, American Association ...
Breaking Medicine Technology: