BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Medicsight (MSHT.OB) Receives Additional Information Request for FDA 510(k) Clearance


1/27/2010 8:11:16 AM

Bookmark and Share

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 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.; Medicsight PLC

RELATED LINKS http://www.mgtci.com

Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES